Anti-reverse fixing structure and implantable medical device

Abstract

The present application provides an anti-reverse fixing structure and an implantable medical device. The anti-reverse fixing structure comprises a fixing substructure used for fixing an implantable medical device to a target organ tissue, an anti-reverse substructure, and a mounting substructure connected to the distal end of the implantable medical device. The fixing substructure is connected to the mounting substructure by means of the anti-reverse substructure; the anti-reverse substructure comprises at least one first anti-reverse part, when the distal end of the first anti-reverse part is subjected to an external force from the distal end to the proximal end of the anti-reverse fixing structure in the axis direction of the anti-reverse fixing structure, the distal end of the first anti-reverse part can be bent and at least partially abut against the target organ tissue. According to the anti-reverse structure provided by the present application, the reliability and safety of an implantable medical device after being implanted to a target organ tissue can be improved, and the anti-reverse fixing structure has a simple structure and is easy to process and assemble.

Description

Anti-reversal fixing structure and implantable medical device Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an anti-reversal fixing structure and an implantable medical device. Background Art

[0002] At present, the fixation methods of leadless pacemakers can be mainly divided into two types: passive wing and active spiral. Among them, the active spiral fixation method has the advantages of a wide range of optional fixing positions and stability and reliability, so it is increasingly widely used. For the active spiral fixation method, it can have an anti-reversal structure to increase the stability and reliability of the fixation. However, the fixation elements of leadless pacemakers in the prior art usually only have the function of preventing the leadless pacemaker from reversing and exiting the myocardial tissue, and are insufficient in preventing the leadless pacemaker from continuously moving into the myocardial tissue. The continuous movement of the leadless pacemaker into the myocardial tissue poses a risk of perforation and poses certain safety hazards. In addition, the structure of the fixation elements with anti-reversal structures in the prior art is usually relatively complex and difficult to process or assemble.

[0003] It should be noted that the information disclosed in the background technology section of this application is only intended to deepen the understanding of the general background technology of this application, and should not be regarded as an admission or any form of implication that the information constitutes prior art already known to those skilled in the art.

[0004] Summary of the Invention

[0005] The technical problem to be solved by the present application is that the fixing elements with an anti-reversal structure in the prior art are prone to cause perforation of the implantable medical device and have a complex structure. An anti-reversal fixing structure and an implantable medical device are provided. The present application can more stably fix the implantable medical device to the target organ tissue and reduce the risk of perforation of the implantable medical device.

[0006] To achieve the above objectives, the present application is implemented through the following technical solutions: an anti-reversal fixing structure for an implantable medical device; the anti-reversal fixing structure includes a fixing substructure for fixing the implantable medical device to a target tissue, an anti-reversal substructure, and a mounting substructure for connecting to a distal end of the implantable medical device;

[0007] The fixed substructure is connected to the mounting substructure via the anti-reversal substructure;

[0008] The anti-reversal substructure includes at least one first anti-reversal portion, which can be deformed when the distal end of the first anti-reversal portion is subjected to an external force from the distal end to the proximal end of the anti-reversal fixing structure along the axis of the anti-reversal fixing structure.

[0009] In order to achieve the above-mentioned object, the present application also provides an implantable medical device, comprising an implantable medical device body, an electrode, a feedthrough, and the above-mentioned anti-reversal fixing structure;

[0010] The electrode is fixedly connected to the distal end of the anti-reversal fixing structure, the proximal end of the anti-reversal fixing structure is fixedly connected to the distal end of the implantable medical device body, and at least one feedthrough wire of the feedthrough passes through the anti-reversal fixing structure and is electrically connected to the electrode.

[0011] Optionally, the implantable medical device further includes a drug plug, which is disposed between the electrode and the anti-reversal fixing structure.

[0012] The anti-reversal fixing structure and implantable medical device provided in this application have at least the following beneficial effects:

[0013] The anti-reversal fixing structure provided by the present application includes a fixing substructure for fixing the implantable medical device to the target organ tissue, an anti-reversal substructure, and a mounting substructure connected to the distal end of the implantable medical device. In this manner, the anti-reversal fixing structure provided by the present application is not only convenient for fixing the implantable medical device to the target organ tissue; but also this modular design makes the anti-reversal fixing structure simple in structure, easy to process, assemble and maintain, thereby saving manpower, material resources and time costs. Furthermore, the anti-reversal substructure of the anti-reversal fixing structure provided by the present application includes at least one first anti-reversal portion. When the distal end of the first anti-reversal portion is subjected to an external force from the distal end to the proximal end of the anti-reversal fixing structure along the axial direction of the anti-reversal fixing structure, the distal end of the first anti-reversal portion can bend and at least partially press against the target organ tissue. Therefore, the anti-reversal fixing structure provided by the present application can not only effectively prevent the implantable medical device from reversing and exiting the target organ tissue (such as preventing the leadless pacemaker from exiting the myocardial tissue), but also prevent the implantable medical device from continuously moving into the target organ tissue and causing perforation (such as the leadless pacemaker continuously moving into the myocardial tissue and causing perforation of the myocardial tissue), thereby improving the reliability and safety of the implantable medical device after implantation into the target organ tissue.

[0014] Since the implantable medical device provided in this application belongs to the same inventive concept as the anti-reversal fixing structure provided in this application, the implantable medical device provided in this application has at least all the advantages of the anti-reversal fixing structure provided in this application. They will not be elaborated here. For more details, please refer to the relevant description of the above-mentioned anti-reversal fixing structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG1 is a schematic structural diagram of a leadless pacemaker using the anti-reversal fixing structure provided by the present application;

[0016] FIG2 is an exploded view of the anti-reversal fixing structure provided in Example 1 of the present application;

[0017] FIG3 is a schematic structural diagram of the fixed spiral in FIG2 ;

[0018] FIG4 is a schematic structural diagram of the first support member in FIG2 ;

[0019] FIG5 is a schematic structural diagram of the first anti-reversal element in FIG2 ;

[0020] FIG6 a is a front view of the first anti-reversal element in FIG2 when subjected to a first external force along the axial direction of the anti-reversal fixing structure from the distal end to the proximal end of the anti-reversal fixing structure;

[0021] FIG6 b is a front view of the first anti-reversal element in FIG2 when subjected to a second external force along the axial direction of the anti-reversal fixing structure from the distal end to the proximal end of the anti-reversal fixing structure;

[0022] FIG6 c is a front view of the first anti-reversal element in FIG2 when subjected to a third external force along the axial direction of the anti-reversal fixing structure from the distal end to the proximal end of the anti-reversal fixing structure;

[0023] FIG6d is a schematic diagram corresponding to FIG6a , viewed from the distal end to the proximal end of the anti-reversal fixing structure along the axial direction of the anti-reversal fixing structure;

[0024] FIG6e is a schematic diagram corresponding to FIG6b , viewed from the distal end to the proximal end of the anti-reversal fixing structure along the axial direction of the anti-reversal fixing structure;

[0025] FIG6f is a schematic diagram corresponding to FIG6c , viewed from the distal end to the proximal end of the anti-reversal fixing structure along the axial direction of the anti-reversal fixing structure;

[0026] FIG7 is an exploded view of the anti-reversal fixing structure provided in Example 2 of the present application;

[0027] FIG8 is a schematic structural diagram of the fixing spiral and the first welding plate in FIG7;

[0028] FIG9 is a schematic structural diagram of the first support member in FIG7 ;

[0029] FIG10a is a cross-sectional view of the first anti-reversal element in FIG7 when subjected to a fourth external force along the axial direction of the anti-reversal fixing structure from the distal end to the proximal end of the anti-reversal fixing structure;

[0030] FIG10 b is a cross-sectional view of the first anti-reversal element in FIG7 when subjected to a fifth external force along the axial direction of the anti-reversal fixing structure from the distal end to the proximal end of the anti-reversal fixing structure;

[0031] FIG10c is a cross-sectional view of the first anti-reversal element in FIG7 when subjected to a sixth external force along the axial direction of the anti-reversal fixing structure from the distal end to the proximal end of the anti-reversal fixing structure;

[0032] FIG10d is a schematic diagram corresponding to FIG10a , viewed from the distal end to the proximal end of the anti-reversal fixing structure along the axial direction of the anti-reversal fixing structure;

[0033] FIG10e is a schematic diagram corresponding to FIG10b , viewed from the distal end to the proximal end of the anti-reversal fixing structure along the axial direction of the anti-reversal fixing structure;

[0034] FIG10f is a schematic diagram corresponding to FIG10c , viewed from the distal end to the proximal end of the anti-reversal fixing structure along the axial direction of the anti-reversal fixing structure;

[0035] FIG11 is an exploded view of the anti-reversal fixing structure provided in Example 3 of the present application;

[0036] FIG12 is a schematic structural diagram of the fixing spiral and the second welding plate in FIG11;

[0037] FIG13 is a schematic structural diagram of the second anti-reversal element, the second welding plate and the fixing spiral in FIG11;

[0038] FIG14a is a front view of the second anti-reversal element in FIG11 when subjected to a seventh external force along the axial direction of the anti-reversal fixing structure from the distal end to the proximal end of the anti-reversal fixing structure;

[0039] FIG14b is a front view of the second anti-reversal element in FIG11 when subjected to an eighth external force along the axial direction of the anti-reversal fixing structure from the distal end to the proximal end of the anti-reversal fixing structure;

[0040] FIG14c is a corresponding schematic diagram of the state shown in FIG14a , viewed from the distal end to the proximal end of the anti-reversal fixing structure along the axial direction of the anti-reversal fixing structure;

[0041] FIG14d is a corresponding schematic diagram of the state shown in FIG14b , viewed from the distal end to the proximal end of the anti-reversal fixing structure along the axial direction of the anti-reversal fixing structure;

[0042] FIG15 is a schematic structural diagram of the mounting member in FIG11;

[0043] FIG16 is a cross-sectional view along the axial direction of the fixing spiral, the second welding plate, the second anti-reversal element and the mounting member after being integrally formed in FIG11 ;

[0044] FIG17 is an exploded view of the anti-reversal fixing structure provided in Example 4 of the present application;

[0045] FIG18 is a schematic structural diagram of the fixing spiral and the third anti-reversal element in FIG17;

[0046] FIG19 is a schematic structural diagram of the second support member in FIG17;

[0047] FIG20a is a front view of the third anti-reversal element in FIG17 when subjected to a ninth external force along the axis of the anti-reversal fixing structure from the distal end to the proximal end of the anti-reversal fixing structure;

[0048] FIG20 b is a front view of the third anti-reversal element in FIG17 when subjected to a tenth external force along the axial direction of the anti-reversal fixing structure from the distal end to the proximal end of the anti-reversal fixing structure;

[0049] FIG20c is a corresponding schematic diagram of the state shown in FIG20a , viewed from the distal end to the proximal end of the anti-reversal fixing structure along the axial direction of the anti-reversal fixing structure;

[0050] FIG20d is a corresponding schematic diagram of the state shown in FIG20b , viewed from the distal end to the proximal end of the anti-reversal fixing structure along the axial direction of the anti-reversal fixing structure;

[0051] FIG21 is a cross-sectional view along the axial direction of the fixing screw, the third anti-reversal element, the second support member and the mounting member after being integrally formed in FIG17;

[0052] The description of the accompanying drawings is as follows:

[0053] Anti-reversal fixing structure-1, electrical component-2, power supply component-3, housing-4, remote docking component-5;

[0054] Stator structure 100; fixing screw 110, variable pitch structure 111, first welding surface 112; connector 120, annular base 121, L-shaped connecting portion 122; first welding plate 131, first positioning structure 1311, second welding surface 1312, welding plate mounting portion 1313; second welding plate 132, third welding surface 1321, second positioning structure 1322, first limiting structure 1323;

[0055] Anti-reversal substructure 200; first support member 211, groove structure 2111, spiral mounting portion 2111a, axis structure 2112, stepped support portion 2112a, connecting shaft 2112b, second anti-reversal portion 2113, side groove 2114, bottom groove 2115; first anti-reversal element 221, first anti-reversal portions 2211, 2221, 2231, first inclined surfaces 2211a, 2221a, 2223a, second inclined surfaces 2211b, 2221b, 2223b, third inclined surfaces 2211c, 2221c, fourth inclined surface 2211d; anti-reversal element mounting portion 2212, clamping block 2212a;

[0056] Second anti-reversal element 222, first anti-reversal chassis 2222, third anti-reversal portion 2223, first annular step structure 22221, second limiting structure 22222, second annular step structure 22223, fourth limiting structure 22224;

[0057] Third anti-reversal element 223, second anti-reversal chassis 2232, third annular step structure 22321, third positioning structure 22322, fourth welding surface 22323, fifth limiting structure 22324;

[0058] Second support member 212, third anti-reversal chassis structure 2121, fourth annular step structure 21211, fifth annular step structure 21212, sixth limiting structure 21214, seventh limiting structure 21215, support seat 21213, fourth anti-reversal portion 2122, fifth inclined surface 2122a, sixth inclined surface 2122b;

[0059] Mounting substructure 300; mounting member 310, through hole 311, third limiting structure 312, sealing plate 320, through hole 321;

[0060] Electrode-400, Feedthrough-500, Feedthrough-600, and Suspension-700. DETAILED DESCRIPTION

[0061] To make the objectives, advantages, and features of the present application more clear, the anti-reversal fixation structure and implantable medical device proposed in the present application are further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and are not in exact proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present application. It should be understood that the drawings in the specification do not necessarily show the specific structure of the present application to scale, and the illustrative features used in the drawings to illustrate certain principles of the present application may also be slightly simplified. The specific design features of the present application disclosed herein, including, for example, specific dimensions, directions, positions, and shapes, will be determined in part by the specific application and environment in which they are used. In addition, in the embodiments described below, the same figure numbers are sometimes used in different drawings to represent the same parts or parts with the same functions, and their repeated descriptions are omitted. In this specification, similar numbers and letters are used to represent similar items. Therefore, once a certain item is defined in one drawing, it does not need to be further discussed in subsequent drawings. Where appropriate, these terms used in this way are interchangeable.

[0062] In the description of this application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", "axis", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application.

[0063] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of such features. Throughout the description of this application, "plurality" means at least two, for example, two, three, etc., unless otherwise specifically defined.

[0064] In this application, unless otherwise specified or limited, the terms "installed," "connected," "connect," "fixed," etc. should be understood in a broad sense. For example, they can refer to fixed connection, detachable connection, or integration; mechanical connection or electrical connection; direct connection or indirect connection through an intermediate medium; internal communication between two elements or interaction between two elements, unless otherwise specified. Those skilled in the art will understand the specific meanings of the above terms in this application based on specific circumstances.

[0065] In this application, unless otherwise expressly specified or limited, when a first feature is "above" or "below" a second feature, it may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Furthermore, when a first feature is "above," "above," or "above" a second feature, it may mean that the first feature is directly above or diagonally above the second feature, or simply means that the first feature is at a higher level than the second feature. When a first feature is "below," "below," or "below" a second feature, it may mean that the first feature is directly below or diagonally below the second feature, or simply means that the first feature is at a lower level than the second feature.

[0066] It should be noted that the "proximal end" described herein is the end close to the operator (i.e., the end away from the target tissue, such as the target organ tissue), and the "distal end" is the end away from the operator (i.e., the end close to the target organ tissue). In particular, the anti-reversal fixing structure provided in this application can be used for various implantable medical devices, without limitation to the specific type and implantation location of the implantable medical device. For example, the implantable medical device can be any one of a cardiac defibrillator, a cardiac pacemaker, a leadless pacemaker, an insulin pump, a medication system, a brain nerve stimulator, and a monitoring system, as well as other types of implantable medical devices other than the above examples. For ease of understanding, this article uses a leadless pacemaker as an example of an implantable medical device to illustrate the anti-reversal fixing structure provided in this application. More specifically, please refer to Figure 1, which schematically shows a structural diagram of a leadless pacemaker with an anti-reversal fixing structure provided in this application. As can be seen from Figure 1, the leadless pacemaker provided in this example includes the anti-reversal fixing structure 1 provided in this application, an electrical component 2 and a power supply component 3 located in a housing 4, and a proximal docking component 5. Specifically, the anti-reversal fixation structure 1 is located at the distal end of the leadless pacemaker. Its primary function is to secure the leadless pacemaker in the myocardial tissue and prevent it from reversing and rotating out. The electrode (not shown in Figure 1; see electrode 400 in Figures 2, 7, 11, or 17 below) is connected to the electrical assembly 2 (more specifically, the electrode is electrically connected to the leadless pacemaker's feedthrough wire via the anti-reversal fixation structure 1. It should be noted that the electrode and the anti-reversal fixation structure 1 are fixedly connected but not electrically connected to each other; the anti-reversal fixation structure 1 supports and secures the electrode), thereby providing pacing and sensing functions. The electrical assembly 2 is the core component of the leadless pacemaker and is primarily responsible for overall control, such as communication with external programmable devices and controlling the electrode's pacing and sensing functions. The power supply assembly 3 is used to provide energy to the electrical assembly 2. The housing 4 protects the electrical assembly 2 and the power supply assembly 3. Furthermore, the housing 4 is typically equipped with a ring electrode (not shown) for sensing myocardial tissue activity. The proximal docking assembly 5 is primarily used for docking with the delivery or retrieval system. Furthermore, to more clearly illustrate the connection relationship between the anti-reversal fixing structure 1 provided by the present application and the leadless pacemaker, other components of the leadless pacemaker are further introduced in the following embodiments 1 to 4. For details, please refer to the electrodes 400, feedthrough 500, feedthrough wire 600, and drug plug 700 shown in Figures 2, 7, 11, or 17. Further details about the electrodes 400, feedthrough 500, feedthrough wire 600, and drug plug 700 of the leadless pacemaker are not described in detail herein. For details, please refer to the relevant technologies known to those skilled in the art.

[0067] It should be further explained that, in order to facilitate understanding and avoid redundancy, this document first provides an overall description of the same or similar components in the anti-reversal fixing structure provided in each embodiment, and then separately describes the differences between each embodiment and other embodiments in specific embodiments. Please refer to each embodiment for details. In addition, the descriptions related to quantities such as "at least one" and "a plurality" in this document are intended to indicate that the number of description objects involved in "at least one" and "a plurality" in this application can be multiple (greater than or equal to 1) and is not limited. It can be 1, 2, 3 or more. When implementing this application, it should be reasonably set according to actual conditions. For example, "at least one first anti-reversal part" hereinafter can be understood to mean that the first anti-reversal part can be 1, 2, 3, or even more, such as 7, 8, etc.

[0068] The core idea of ​​the present application is to provide an anti-reversal fixing structure 1 for an implantable medical device. For example, please refer to Figure 2, Figure 7, Figure 11 or Figure 17, wherein Figure 2 is a structural explosion diagram of the anti-reversal fixing structure 1 provided in Example 1 of the present application, Figure 7 is a structural explosion diagram of the anti-reversal fixing structure 1 provided in Example 2 of the present application, Figure 11 is a structural explosion diagram of the anti-reversal fixing structure 1 provided in Example 3 of the present application, and Figure 17 is a structural explosion diagram of the anti-reversal fixing structure 1 provided in Example 4 of the present application. It is not difficult to see from Figures 2, 7, 11 or 17 that the anti-reversal fixing structure 1 provided in the present application includes a fixing substructure 100 for fixing the implantable medical device to the target organ tissue, an anti-reversal substructure 200 and a mounting substructure 300 connected to the distal end of the implantable medical device. The fixing substructure 100 is connected to the mounting substructure 300 through the anti-reversal substructure 200; the anti-reversal substructure 200 includes at least one first anti-reversal portion (marked as 2211 in Examples 1 and 2, 2221 in Example 3, and 2231 in Example 4). When the distal end of the first anti-reversal portion is subjected to an external force from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axial direction of the anti-reversal fixing structure 1, the first anti-reversal portion can be deformed. Specifically, the distal end of the first anti-reversal portion can bend and at least partially resist the target organ tissue.

[0069] It can be seen that the anti-reversal fixing structure 1 provided by the present application includes a fixing substructure 100 for fixing the implantable medical device to the target organ tissue, an anti-reversal substructure 200, and a mounting substructure 300 connected to the distal end of the implantable medical device. With such an arrangement, the anti-reversal fixing structure 1 provided by the present application is not only convenient for fixing the implantable medical device to the target organ tissue; but also, this modular design makes the anti-reversal fixing structure 1 simple in structure, easy to process, assemble, and maintain, thereby saving manpower, material resources, and time costs. Furthermore, the anti-reversal substructure 200 of the anti-reversal fixing structure 1 provided by the present application includes at least one first anti-reversal portion. When the distal end of the first anti-reversal portion is subjected to an external force from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axis of the anti-reversal fixing structure 1, the distal end of the first anti-reversal portion can bend and at least partially press against the target organ tissue. Therefore, the anti-reversal fixing structure 1 provided in the present application can not only effectively prevent the implantable medical device from reversing and exiting the target organ tissue (such as preventing the leadless pacemaker from exiting the myocardial tissue), but also prevent the implantable medical device from continuously moving into the target organ tissue and causing perforation (such as the leadless pacemaker continuously moving into the myocardial tissue and causing perforation of the myocardial tissue), thereby improving the reliability and safety of the implantable medical device after implantation into the target organ tissue.

[0070] It should be noted that the present application does not limit the form in which the first anti-reversal portion is bent. For example, in some embodiments, such as Example 1 and Example 2 below, the bending of the distal end of the first anti-reversal portion means that the distal end of the first anti-reversal portion can bend radially outward (i.e., bend along the radial direction of the anti-reversal fixing structure toward the direction away from the axis, and the radial direction is a direction perpendicular to the axis direction); in other embodiments, such as Example 3 and Example 4 below, the bending of the distal end of the first anti-reversal portion means that the distal end of the first anti-reversal portion can bend axially toward the proximal end (i.e., bend toward the proximal end along the axial direction of the anti-reversal fixing structure). In yet other embodiments, the distal end of the first anti-reversal portion can also bend axially toward the proximal end while bending radially outward. For more details, please refer to the relevant description below, which will not be expanded here.

[0071] In some exemplary embodiments, please continue to refer to Figures 2, 7, 11 or 17. It is not difficult to find from Figures 2, 7, 11 or 17 that the anti-reversal substructure 200 includes a plurality of first anti-reversal portions (referenced as 2211 in Examples 1 and 2, 2221 in Example 3, and 2231 in Example 4), and the plurality of first anti-reversal portions are arranged around the axis of the anti-reversal fixing structure 1. Thus, by arranging the first anti-reversal portions around the axis of the anti-reversal fixing structure 1, a foundation is laid for the distal end of the first anti-reversal portion to bend outwardly along the radial direction of the anti-reversal fixing structure 1 and at least partially abut against the target organ tissue; further, when the first anti-reversal portion bends outward, this arrangement of the first anti-reversal portion around the axis of the anti-reversal fixing structure 1 can also make the circumferential force of the anti-reversal substructure 200 more uniform, thereby ensuring that the implantable medical device does not deflect and remains in the preset implant position, thereby further improving the reliability and safety of the implantable medical device after implantation.

[0072] Optionally, the first anti-reversal part is made of a flexible biocompatible material, and the deformation that can occur in the first anti-reversal part causes the height of the first anti-reversal part along the axial direction to be reduced and / or the projected area of ​​the first anti-reversal part along the axial direction to be enlarged. Thus, the first anti-reversal part is made of a flexible biocompatible material, which can ensure that the first anti-reversal part is easily deformed when subjected to external force (for example, in Example 1 and Example 2, when the distal end of the first anti-reversal part is subjected to an external force from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axial direction of the anti-reversal fixing structure 1, the distal end of the first anti-reversal part can bend outward along the radial direction of the reversal fixing structure 1 and at least partially resist the target organ tissue); and the biocompatible material is compatible with the target organ tissue and will not cause an immune reaction or rejection reaction, thereby ensuring the safety of the anti-reversal fixing structure 1 after implantation into the target organ tissue.

[0073] Please continue to refer to Figures 2, 7, 11 or 17. It is not difficult to see from Figures 2, 7, 11 or 17 that the fixed substructure 100 includes a fixed screw 110 for connecting to the target organ tissue, the axial direction of the fixed screw 110 is consistent with the axial direction of the anti-reversal fixed structure 1; the proximal end of the fixed screw 110 is fixedly connected to the distal end of the anti-reversal substructure 200; the axial direction of the anti-reversal fixed structure 1 is the direction of the line connecting the proximal end and the distal end of the anti-reversal fixed structure 1. Therefore, in the process of implanting the implantable medical device into the target organ tissue through the anti-reversal fixed structure 1 provided by the present application, the design mode in which the axial direction of the fixed screw 110 is consistent with the axial direction of the anti-reversal fixed structure 1 and the proximal end of the fixed screw 110 is connected (optionally, fixedly connected) to the distal end of the anti-reversal substructure 200 is not only easy to process and assemble, but also more convenient for the anti-reversal fixed structure 1 provided by the present application to drive the implantable medical device to be implanted into the target organ tissue.

[0074] Optionally, in some embodiments, the fixing spiral 110 is made of a biocompatible metal material; in other embodiments, part of the surface of the fixing spiral 110 may also have a non-metallic coating. Thus, the fixing spiral 110 is made of a biocompatible metal material. On the one hand, the biocompatible material is compatible with the target organ tissue and will not cause immune reactions and rejection reactions, thereby ensuring the safety of the anti-reversal fixing structure 1 after implantation into the target organ tissue. On the other hand, the metal material can also ensure that the fixing spiral 110 has excellent stability and durability. Furthermore, the use of a non-metallic coating can prevent the fixing spiral 110 from being electrically conductive with the myocardium, so that when the fixing spiral 110 is electrically connected to the electrical component 2 through a feedthrough, the fixing spiral 110 can be used as an antenna, which can ensure the realization of the antenna function. Specifically, the material of the biocompatible metal material includes but is not limited to stainless steel, nickel titanium alloy, MP35N and 35NLT and other commonly used metal materials for the active fixing spiral 110 of the electrode wire. The material of the non-metallic coating on the surface of the fixing spiral 110 includes, but is not limited to, Parylene-C, polypropylene, silicone, polyethylene, polyurethane, nylon, polyurethane, polyimide, polyetheretherketone, and polycarbonate.

[0075] Example 1

[0076] The present embodiment provides an anti-reversal fixing structure 1. Specifically, referring to FIG2 , as previously described, the stator structure 100 of the anti-reversal fixing structure 1 provided in the present embodiment includes a fixing screw 110. Since the fixing screw 110 has been described above, it will not be expanded here. In addition to the fixing screw 110, the stator structure 100 of the anti-reversal fixing structure 1 provided in the present embodiment also includes a first welding plate 131; the distal end of the first welding plate 131 (i.e., the left end of the first welding plate 131 in FIG2 ) is connected (optionally, fixedly connected) to the proximal end of the fixing screw 110 (i.e., the right end of the fixing screw 110 in FIG2 ), and the proximal end of the first welding plate 131 (i.e., the right end of the first welding plate 131 in FIG2 ) is connected (optionally, fixedly connected) to the distal end of the anti-reversal substructure 200 (i.e., the left end of the anti-reversal substructure 200 in FIG2 ). As an optional embodiment, the proximal end of the first welding plate 131 is connected (optionally, fixedly connected) to the first support member 211. Thus, this connection method in which the fixing spiral 110 is fixedly connected to the first welding pad 131 and the first welding pad 131 is fixedly connected to the distal end of the anti-reversal substructure 200 can, on the one hand, fix the implantable medical device at a preset position of the target organ tissue (for example, fixing a leadless pacemaker at a designated position of the myocardium, such as the apex, ventricular septum, right atrial appendage, and smooth muscle) and facilitate processing and assembly, while also further strengthening the connection between the fixing spiral 1110 and the first support member 211; on the other hand, it is also convenient to connect to one of the feedthrough wires 600 of the feedthrough 500 to achieve an electrical connection. It should be noted that the present application does not limit the connection method between the fixing spiral 110 and the first welding pad 131. For example, the fixing spiral 110 and the first welding pad 131 can be connected by laser welding, etc.

[0077] Optionally, the first welding plate 131 is made of a biocompatible metal material. On the one hand, the biocompatible material is compatible with the target organ tissue and will not cause immune reactions or rejection reactions, thereby laying the foundation for the safety of the anti-reversal fixation structure 1 after implantation into the target organ tissue; on the other hand, the first welding plate 131 is made of a metal material, which is also more convenient for fixed connection with the fixing spiral 110 (such as welding) and provides better support for the fixing spiral 110, thereby improving the stability of the fixing spiral 110 along the axial direction. Specifically, biocompatible metal materials include but are not limited to stainless steel, nickel-titanium alloy, MP35N and 35NLT, etc.

[0078] In some exemplary embodiments, please refer to Figure 2. It can be seen from Figure 2 that the fixing substructure 100 also includes a connector 120, which is at least partially located in the fixing spiral 110 along the axial direction of the anti-reversal fixing structure 1, and the distal end of the connector 120 (the left end of the connector 120 in Figure 2) is configured to fix the electrode 400 of the implantable medical device; the proximal end of the connector 120 (the right end of the connector 120 in Figure 2) is connected to the distal end of the anti-reversal substructure 200 (optionally, fixedly connected). As an optional embodiment, the proximal end of the connector 120 is connected to the first support member 211 (optionally, fixedly connected). Thus, the fixing substructure 100 of the anti-reversal fixing structure 1 provided in this embodiment includes a connector 120, which can not only well support the electrode 400 and the embossment 700, but also assist in preventing the first welding plate 131 from moving along the axial direction of the anti-reversal fixing structure 1, further improving the firmness of the connection between the first welding plate 131 and the fixing spiral 110 and the anti-reversal substructure 200 (as an optional embodiment, the proximal end of the fixing spiral 110 is fixedly connected to the first support member 211). Optionally, the connector 120 is made of a biocompatible non-metallic material. Specifically, biocompatible non-metallic materials include but are not limited to materials such as polypropylene, silicone, polyethylene, polyurethane, nylon, polyurethane, polyimide, polyetheretherketone and polycarbonate. The connector 120 and the first support member 211 described below can be connected by a fixed connection method of overlapping, filling and curing resin glue.

[0079] In some exemplary embodiments, please refer to Figures 2, 3, 4 and 5, wherein Figure 3 is a schematic structural diagram of the fixing screw 110 in Figure 2, Figure 4 is a schematic structural diagram of the first support member 211 in Figure 2, and Figure 5 is a schematic structural diagram of the first anti-reversal element 221 in Figure 2. As can be seen from Figures 2, 3, 4 and 5, the anti-reversal substructure 200 includes a circumferentially clamped first support member 211 (see Figure 4) and a first anti-reversal element 221 (see Figure 5), the distal end of the first support member 211 is connected (optionally, fixedly connected) to a portion of the fixing screw 110 and the proximal end of the connector 120, and the proximal end of the first support member 211 is connected (optionally, fixedly connected) to the distal end of the mounting substructure 300; the first anti-reversal element 221 includes a first anti-reversal portion 2211 and an anti-reversal element mounting portion 2212, and the first anti-reversal portion 2211 is disposed on the anti-reversal element mounting portion 2212.

[0080] As an option, the first support member 211 is made of biocompatible non-metallic materials, such as polypropylene, silicone, polyethylene, polyurethane, nylon, polyurethane, polyimide, polyetheretherketone and polycarbonate. Therefore, the first support member 211 is made of biocompatible non-metallic materials, which makes it easier for the first support member 211 to be fixedly connected to the first welding plate 131 and the connector 120, such as by using a fixed connection method of overlapping filling and curing resin glue. During assembly, the first welding plate 131 can be installed in the first support member 211 first, and then the fixing screw 110 can be installed in the fixed position of the first support member 211 (such as the spiral mounting portion 2111a below) and welded to the first welding plate 131; and then the connector 120 can be fixedly connected to the first support member 211.

[0081] As described above, in some exemplary embodiments, the distal end of the first anti-reversal portion 2211 in this embodiment can bend and at least partially press against the target organ tissue, including: the distal end of the first anti-reversal portion 2211 can bend radially outward and at least partially press against the target organ tissue.

[0082] Specifically, in some exemplary embodiments, please continue to refer to Figures 2 and 4, a side groove 2114 and a bottom groove 2115 are provided on the first support member 211; the first anti-reversal portion 2211 is clamped in the side groove 2114 at the corresponding position, and the anti-reversal element mounting portion 2212 is located in the bottom groove 2115 and is clamped between the first support member 211 and the mounting substructure 300. Therefore, the anti-reversal fixing structure 1 provided in this embodiment adopts a design in which the first anti-reversal part 2211 is clamped in the side groove 2114 of the first support member 211, and the anti-reversal element mounting part 2212 is located in the bottom groove 2115 and clamped between the first support member 211 and the mounting substructure 300. This not only makes the connection between the first anti-reversal part 2211 and the first support member 211 along the axial direction and radial direction (that is, the direction perpendicular to the axial direction, the radial direction will not be explained below) of the anti-reversal fixing structure 1 more firm; but also when the distal end of the first anti-reversal part 2211 is subjected to an external force from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axial direction of the anti-reversal fixing structure 1, it is also more conducive to the distal end of the first anti-reversal part 2211 to bend outward along the radial direction of the anti-reversal fixing structure 1.

[0083] In some exemplary embodiments, referring to Figures 2, 4, and 5, the first anti-reversal portion 2211 extends in a direction from the proximal end of the first anti-reversal element 221 to the distal end of the first anti-reversal element 221, and the anti-reversal element mounting portion 2212 is annular and sleeved within the bottom groove 2115 of the first support member 211. Thus, this annular sleeve connection method restricts the movement of the first anti-reversal element 221 along the axis of the anti-reversal fixing structure 1 via the bottom groove 2115, and restricts the circumferential rotation of the first anti-reversal element 221 via the side grooves 2114, further enhancing the secure connection between the first support member 211 and the first anti-reversal element 221 and facilitating the arrangement of the first anti-reversal portion 2211 around the axis of the anti-reversal fixing structure 1.

[0084] In some exemplary embodiments, referring to FIG5 , the inner surface of the anti-reversal element mounting portion 2212 is provided with intermittently arranged snap-fit ​​blocks 2212a, which extend inwardly along an axis perpendicular to the anti-reversal fixing structure 1. Matching snap-fit ​​grooves (not shown) are provided at positions corresponding to the snap-fit ​​blocks 2212a in the bottom groove 2115, and the snap-fit ​​blocks 2212a extend into the snap-fit ​​grooves in a one-to-one correspondence. Thus, this one-to-one connection method, through which the snap-fit ​​grooves and snap-fit ​​blocks 2212a correspond, not only facilitates assembly but also enhances the securement of the connection between the first support member 211 and the first anti-reversal element 221.

[0085] In some exemplary embodiments, please continue to refer to Figures 2 and 4. A groove structure 2111 is provided at the distal end of the first support member 211. A spiral mounting portion 2111a is provided on the inner sidewall of the groove structure 2111. The fixing spiral 110 is partially embedded in the spiral mounting portion 2111a. Thus, by providing the groove structure 2111 at the distal end of the first support member 211, on the one hand, a foundation is laid for providing the spiral mounting portion 2111a on the inner sidewall of the groove structure 2111. On the other hand, the provision of the groove structure 2111 also lays the foundation for the first support member 211 to accommodate the first welding plate 131 and the connector 120. This not only further enhances the supporting function of the first support member 211, but also effectively reduces the axial dimension of the anti-reversal fixing structure 1. Furthermore, the provision of the spiral mounting portion 2111a not only facilitates the assembly of the fixing spiral 110, but also effectively limits the deformation of the fixing spiral 110 to the axial direction along the anti-reversal fixing structure 1, thereby effectively reducing the risk of perforation of target organ tissue (such as myocardial perforation due to excessive deformation of the axis of the fixing spiral 110).

[0086] Alternatively, referring to Figures 2 and 4 , the spiral mounting portion 2111a is a spiral groove, and the portion of the fixing screw 110 embedded in the spiral groove is adapted to the spiral groove. Thus, the design of the portion of the fixing screw 110 embedded in the spiral groove being adapted to the spiral groove can ensure stability between the portion of the fixing screw 110 embedded in the spiral groove and the first support member 211, thereby further improving the reliability of the fixing screw 110 in deformation along the axis of the anti-reversal fixing structure 1.

[0087] In some exemplary embodiments, please continue to refer to FIG. 4 , the first support member 211 further includes at least one second anti-reversal portion 2113 disposed on the inner sidewall of the groove structure 2111 and in communication with the spiral mounting portion 2111a. The second anti-reversal portion 2113 is a recessed structure, the opening direction of the recessed structure being the same as the opening direction of the spiral groove, and the distal end of the recessed structure is also in an open state. Thus, by disposing at least one second anti-reversal portion 2113 in communication with the spiral mounting portion 2111a on the inner sidewall of the groove structure 2111, and designing the second anti-reversal portion 2113 as a recessed structure having the same opening direction as the opening direction of the spiral groove and an open distal end, the fixation spiral 110 can be further restricted from reversing to prevent it from exiting the target organ tissue. Specifically, the fixing spiral 110 is usually a biocompatible metal material, while the first support member 211 is usually a biocompatible non-metallic material, and the second anti-reversal portion 2113 is a recessed structure in an open state. Therefore, after implantation into the target organ tissue, the softer target organ tissue will be embedded in the second anti-reversal portion 2113 with a recessed structure and the end of its open end will press against the target organ tissue to achieve the anti-reversal function.

[0088] Optionally, the fixation spiral 110 has a variable pitch structure 111. This variable pitch design not only facilitates assembly of the fixation spiral 110 with the spiral mounting portion 2111a (shaped as a spiral groove), but also effectively reduces the risk of perforation of target organ tissue. Specifically, the fixation spiral 110 can be designed with a pitch greater at the distal end than at the proximal end, thereby further shortening the length of the fixation spiral while ensuring fixation and preventing myocardial perforation.

[0089] In some exemplary embodiments, please continue to refer to FIG4 . As can be seen from FIG4 , the first support member 211 further includes an axial structure 2112 provided at the bottom of the groove structure 2111. The shape of the axial structure 2112 is adapted to the proximal end of the connector 120 and the proximal end of the first welding pad 131 of the stator structure 100 (see FIG8 below for details); the connector 120 and the first welding pad 131 are connected (optionally, fixedly connected) to the first support member 211 via the axial structure 2112. Therefore, the provision of the axial structure 2112 not only facilitates the fixed connection of the first support member 211 with the connector 120 and the first welding pad 131, but also can further enhance the supporting performance of the first support member 211. Furthermore, the design of the groove wall of the groove structure 2111 of the first support member 211, the fixing spiral 110, the connecting member 120, the first welding plate 131 and the axial structure 2112, which are nested from the outside to the inside, can effectively reduce the overall size of the anti-reversal fixing structure 1 while ensuring that the first support member 211 has good supporting performance, and save resources while effectively reducing the discomfort caused to the patient by the implantable medical device.

[0090] In some exemplary embodiments, please continue to refer to Figure 5. It can be seen from Figure 5 that the first anti-reversal portion 2211 is a plate-like structure, and the plate-like structure is provided with a first inclined surface 2211a having a first angle with the cross-section of the anti-reversal fixing structure 1, a second inclined surface 2211b having a second angle with the cross-section of the anti-reversal fixing structure 1, and a third inclined surface 2211c having a third angle with the cross-section of the anti-reversal fixing structure 1. In which, the first inclined surface 2211a is located at the end of the plate-like structure away from the anti-reversal element mounting portion 2212, and the inclination direction of the first inclined surface 2211a (as shown in Figure 5, inclination from the lower left to the upper right) is contrary to the screwing-out direction of the fixing screw 110 (as shown in Figure 3, the distal end of the fixing screw 110 rotates from the upper left to the lower right); the second inclined surface 2211b and the third inclined surface 2211c both extend from the proximal end of the plate-like structure to the distal end of the plate-like structure, and the third inclined surface 2211c is adjacent to the first inclined surface 2211a and the second inclined surface 2211b, the values ​​of the first angle, the second angle and the third angle are all not 0, and the value of the first angle is less than the value of the second angle, and the value of the third angle is less than 90°.

[0091] Thus, the first anti-reversal portion 2211 adopts a plate-shaped design, which is not only easy to process, but also allows the side groove 2114 of the first support member 211 to accommodate the first anti-reversal portion 2211 when no external force is applied. Furthermore, the inclination direction of the first inclined surface 2211a located at the end of the plate-shaped structure away from the anti-reversal element mounting portion 2212 is set to be opposite to the rotation direction of the fixing screw 110, and the values ​​of the first angle, the second angle, and the third angle are all non-zero, and the value of the first angle is smaller than the value of the second angle. Please refer to Figures 2 and 5 for details. The thumb of the right hand points to the left in Figure 2 (that is, the distal end of the anti-reversal fixing structure 1), and the other four fingers are clenched into a fist. When the fixing spiral 110 continues to enter the target organ tissue along the axial direction, since the first angle between the first inclined surface 2211a and the cross-section of the anti-reversal fixing structure 1 is smaller than the second angle between the second inclined surface 2211b and the cross-section of the anti-reversal fixing structure 1, the fixing spiral 110 is caused to rotate in the reverse direction (taking Figure 2 as an example, the thumb of the right hand points from the right to the left, and the other four fingers are clenched into a fist, and the direction of the other four fingers from the fingertips to the base of the fingers is reverse rotation) and the resistance difference between the forward rotation (opposite to the direction of the reverse rotation above) is greater during reverse rotation, thereby avoiding the reversal of the fixing spiral 110, and thus enabling the anti-reversal fixing structure 1 provided in the present application to firmly fix the implantable medical device on the target organ tissue, thereby playing an anti-reversal function. Furthermore, the value of the third angle is less than 90°, so that the first anti-reversal portion 2211 has a tendency to bend outward in the radial direction and be resisted by the target organ tissue when the force applied by the target organ tissue along the axial direction of the anti-reversal fixing structure 1 is applied, thereby increasing the contact area between the first anti-reversal portion 2211 and the target organ tissue (such as the myocardium) and increasing the resistance of the implantable medical device (such as a leadless pacemaker) as a whole to continue entering the target organ tissue along the axial direction, thereby reducing the risk of perforation of the target organ tissue.

[0092] For example, the plate-like structure can be a straight plate, and the material of the mounting member 310 can be pure titanium. More specifically, the first angle between the first inclined surface 2211a and the cross-section of the anti-reversal fixing structure 1 (the angle between the first inclined surface 2211a and the horizontal plane in the illustrated direction of FIG5 ) can be selected to be between 30° and 60°, and the second angle between the second inclined surface 2211b and the cross-section of the anti-reversal fixing structure 1 (the angle between the second inclined surface 2211b and the horizontal plane in FIG5 ) can be selected to be between 60° and 90°. It should be noted that, as will be understood by those skilled in the art, this application does not limit the specific values ​​of the first angle, the second angle, and the third angle.

[0093] In some other embodiments, the plate-like structure may also be a curved plate, which will not be described in detail here.

[0094] Optionally, referring to FIG5 , the first anti-reversal portion 2211 further includes a fourth bevel 2211d, which is adjacent to the first bevel 2211a, the second bevel 2211b, and the third bevel 2211c. Together, the fourth bevel 2211d and the first bevel 2211a form the distal end of the plate-like structure. Along the circumference of the anti-reversal element mounting portion 2212, the length of the first bevel 2211a is greater than the length of the fourth bevel 2211d. Thus, the provision of the first bevel 2211a, the second bevel 2211b, the third bevel 2211c, and the fourth bevel 2211d prevents reversal of the fixation screw 110 and effectively reduces the risk of perforation of target organ tissue. Furthermore, the provision of the first bevel 2211a, the second bevel 2211b, the third bevel 2211c, and the fourth bevel 2211d can prevent the fixation screw 110 from reversing and effectively reduce the risk of perforation of target organ tissue. Furthermore, the provision of the first bevel 2211a, the second bevel 2211b, the third bevel 2211c, and the fourth bevel 2211d can reduce discomfort to the target organ tissue caused by the sharp angle formed at the distal end of the first anti-reversal portion 2211 due to the lack of a transition between the first bevel 2211a and the second bevel 2211b.

[0095] It should be noted that this application does not limit the number of first anti-reversal parts 2211. When implementing this application, a reasonable number can be set based on the selected materials and torque test results, combined with the size restrictions of the anti-reversal fixing structure 1. As an option, the number of first anti-reversal parts 2211 can be set to 2 to 8. This configuration reduces the risk of perforation of target organ tissue while taking into account both processing difficulty and assembly efficiency. In addition, as an optional embodiment, the first anti-reversal element 221 is a one-piece structure, thereby further improving assembly efficiency.

[0096] More specifically, please see Figures 6a to 6f. 6a is a front view of the first anti-reversal element 221 in FIG2 when it is subjected to a first external force from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axial direction of the anti-reversal fixing structure 1; FIG6b is a front view of the first anti-reversal element 221 in FIG2 when it is subjected to a second external force from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axial direction of the anti-reversal fixing structure 1; FIG6c is a front view of the first anti-reversal element 221 in FIG2 when it is subjected to a third external force from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axial direction of the anti-reversal fixing structure 1; FIG6d is a schematic diagram corresponding to FIG6a observed from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axial direction of the anti-reversal fixing structure 1; FIG6e is a schematic diagram corresponding to FIG6b observed from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axial direction of the anti-reversal fixing structure 1; and FIG6f is a schematic diagram corresponding to FIG6c observed from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axial direction of the anti-reversal fixing structure 1. From Figures 6a to 6f , it can be seen not only that the first anti-reversal portion 2211 bends when subjected to different external forces (where the first external force is less than the second external force, and the second external force is less than the third external force), but also that the first anti-reversal portion 2211 bends outwardly in the radial direction of the anti-reversal fixing structure 1, thereby increasing the radial profile of the first anti-reversal element 221 (thereby increasing the radial contact area of ​​the first anti-reversal element 221 with the target organ tissue). Furthermore, the positional relationship between the first support member 211, the fixing screw 110, and the first anti-reversal element 221 can be more clearly seen, further confirming that the provision of the first support member 211 not only ensures the secure connection between the fixing screw 110, the first welding plate 131, the connector 120, and the first anti-reversal element 221, but also effectively prevents the fixing screw 110 from undergoing significant radial deformation.

[0097] In some exemplary embodiments, please continue to refer to FIG. 2 , which shows that the mounting substructure 300 includes a mounting member 310 having a through-hole 311. The proximal end of the first support member 211 extends into the through-hole 311 and is connected to the mounting member 310 (optionally, a fixed connection is achieved, including but not limited to methods such as filling with a curing resin adhesive). Thus, the fixed connection between the proximal end of the first support member 211 extending into the through-hole 311 and the mounting member 310 effectively solves the connection problem between non-metallic materials (the first support member 211 is typically a non-metallic material) and metal materials (the mounting member 310 is typically a metal material).

[0098] Optionally, the proximal end of the first support member 211 is provided with at least one columnar protrusion adapted to the through hole 311 of the mounting member 310, and the columnar protrusion extends into the corresponding through hole 311, and then filled with curing resin glue and other methods to further enhance the firmness of the connection between the two. Optionally, the proximal end of the columnar protrusion may also have a bending structure, and after the bending structure of the columnar protrusion passes through the through hole 311 of the mounting member 310, it abuts against the proximal end face of the mounting member 310 to further enhance the firmness of the connection between the first support member 211 and the mounting member 310. In addition, it is understandable that in addition to the through hole 311 for connection with the first support member 211, the mounting member 310 also has a through hole (not shown in the figure) for the feed wire 600 to pass through, which will not be explained in detail here. There can be multiple columnar protrusions, and 2 can be selected.

[0099] More specifically, the mounting member 310 is made of pure titanium, which makes it easier to weld and connect with other structures of the implantable medical device (such as the housing 4 of a leadless pacemaker). This not only ensures the firmness of the connection between the anti-reversal fixing structure 1 and other structures of the implantable medical device, but also serves to seal and protect the feedthrough wire 600.

[0100] In some exemplary embodiments, please continue to refer to FIG. 2 , which shows that the mounting substructure 300 further includes a sealing disk 320 having a through hole 321. The sealing disk 320 is connected (optionally, fixedly connected) to the proximal end of the mounting substructure 300. The through hole 321 is configured to pass a feedthrough 600. Thus, the provision of the sealing disk 320 achieves a sealing effect on the implantable medical device.

[0101] Example 2

[0102] This embodiment provides an anti-reversal fixing structure 1. As previously mentioned, the anti-reversal fixing structure 1 provided by this embodiment is shown in FIG7 . As can be seen from FIG7 , the anti-reversal fixing structure 1 provided by this embodiment is substantially similar to the anti-reversal fixing structure 1 provided by Example 1. The fixing substructure 100 of the anti-reversal fixing structure 1 provided by this embodiment also includes a fixing screw 110, a connecting member 120, and a first welding plate 131. The anti-reversal substructure 200 also includes a first support member 211 and a first anti-reversal element 221. The mounting substructure 300 also includes a mounting member 310 and a sealing plate 320. In order to avoid redundancy, the parts that are the same as the anti-reversal fixing structure 1 provided in Example 1, such as the connecting member 120, the anti-reversal substructure 200, the mounting member 310 and the sealing disk 320, and the materials of each component (for example, the first welding disk 131 can be made of a biocompatible metal material, and the first supporting member 211 can be made of a biocompatible non-metallic material, which are not listed one by one), etc., will not be described in detail in this embodiment. For more detailed information, please refer to the relevant description of Example 1 for adaptive understanding. The following only describes the differences from Example 1.

[0103] First, the connection method of the fixing spiral 110 and the first welding disc 131 of the anti-reversal fixing structure 1 provided in this embodiment is different from that of Example 1. Specifically, please refer to Figure 8, which schematically shows the structural diagram of the fixing spiral 110 and the first welding disc 131 in Figure 7. A first welding surface 112 is provided at the proximal end of the fixing spiral 110 (i.e., the lower end of the fixing spiral 110 in Figure 8), and a second welding surface 1312 matching the first welding surface 112 is provided at the distal end of the first welding disc 131 (i.e., the upper end of the first welding disc 131 in Figure 8), and the first welding surface 112 and the second welding surface 1312 are connected (optionally, fixedly connected). Thus, by providing the first welding surface 112 at the proximal end of the fixing spiral 110 and correspondingly providing the second welding surface 1312 at the distal end of the first welding disc 131, the connection between the fixing spiral 110 and the first welding disc 131 is more convenient. For example, the first welding surface 112 and the second welding surface 1312 can be laser welded to securely connect the fixing screw 110 to the first welding plate 131. It should be noted that the present application does not limit the welding method of the first welding surface 112 and the second welding surface 1312. In addition to laser welding, other welding methods such as gas flame, arc, electron beam, friction, and ultrasonic welding can also be used.

[0104] Optionally, the first welding plate 131 further includes a first positioning structure 1311 for positioning the spiral direction of the fixing screw 110. The first positioning structure 1311 enables the first welding surface 112 of the fixing screw 110 to be welded to the second welding surface 1312 according to a preset spiral direction. Thus, positioning the spiral direction of the fixing screw 110 by the first positioning structure 1311 not only simplifies and speeds up the assembly of the fixing screw 110 and the first welding plate 131, but also ensures that the fixing screw 110 is fixedly connected to the first welding plate 131 according to the preset spiral direction. Optionally, the first positioning structure 1311 is a block-shaped protruding structure. Therefore, when welding the fixing spiral 110 and the first welding plate 131, first, the end of the fixing spiral 110 provided with the first welding surface 112 is pressed against the side of the first positioning structure 1311 facing the second welding surface 1312 (the right side of the first positioning structure 1311 in Figure 8); then, the first welding surface 112 and the second welding surface 1312 are welded along the spiral direction of the fixing spiral 110, thereby realizing the welding connection between the first welding surface 112 and the second welding surface 1312 according to the preset spiral direction.

[0105] In some exemplary embodiments, the first welding pad 131 further includes a welding pad mounting portion 1313 located at the proximal end of the first welding pad 131 (i.e., the lower end of the first welding pad 131 in FIG8 ). The welding pad mounting portion 1313 is adapted to and connected (optionally, fixedly connected) to the distal end of the anti-reversal substructure 200 (i.e., connected to the axial structure 2112 of the first support member 211). Thus, the provision of the welding pad mounting portion 1313 makes assembly of the first welding pad 131 and the anti-reversal substructure 200 simpler and faster, and ensures that the first welding pad 131 is fixedly connected to the anti-reversal substructure 200 according to a preset mounting position, thereby ensuring that the rotation direction of the fixing screw 110 is contrary to the inclination direction of the first inclined surface 2211a of the first anti-reversal portion 2211. Exemplarily, the welding pad mounting portion 1313 is a first block-shaped structure that protrudes toward the proximal end of the anti-reversal fixing structure 1 and extends inward in the radial direction. Specifically, please refer to FIG9 , which schematically shows a schematic structural diagram of the first support member 211 in FIG7 . As can be seen from FIG9 , as an option, there can be two first block structures, and the distance between the two block structures is adapted to the distance between adjacent stepped support portions 2112a (for details about the stepped support portion 2112a, please refer to the following) of the axial structure 2112 of the first support member 211 shown in FIG9 ; a second block structure adapted to the first block structure is provided on the side of the stepped support portion 2112a (not shown in FIG9 , specifically a bump on the left side of the end point of the lead indicating 2112a). When the first welding pad 131 and the first support member 211 are fixed, the first block structure is nested between the second block structure and the bottom of the groove structure 2111 of the first support member 211, and one of the side surfaces of the first block structure (i.e., the welding pad mounting portion 1313) abuts against the side surface of the stepped support portion 2112a located below the second block structure. This stacked and sleeved connection between the first block structure and the second block structure makes the connection between the first welding pad 131 and the first support member 211 in the axial direction more secure.

[0106] In addition, the connection method between the first support member 211 and the fixing screw 110 of the anti-reversal fixing structure 1 provided in this embodiment is different from that in Example 1. Specifically, in some exemplary embodiments, please continue to refer to Figure 9, which is different from the first support member 211 of the anti-reversal fixing structure 1 provided in Example 1 (please refer to the schematic diagram of the first support member 211 of Example 1 given in Figure 4): the axial structure 2112 of the first support member 211 provided in this embodiment includes at least one stepped support portion 2112a extending radially from the axial center of the first support member 211 to the side wall of the first support member 211, and the stepped support portion 2112a includes a first step (not marked in the figure) close to the side wall and a second step (not marked in the figure) close to the axial center, and the height of the first step is less than the height of the second step. Thus, the sidewalls and second steps of the first support member 211 can confine the fixing screw 110 to the first step and between the sidewalls and second steps of the first support member 211. This not only ensures the stability of the connection between the portion of the fixing screw 110 embedded in the first support member 211 and the first support member 211, but also further improves the reliability of the fixing screw 110 in deforming along the axis of the anti-reversal fixing structure 1, thereby effectively reducing the overall size of the anti-reversal fixing structure 1. Optionally, there are three stepped support portions 2112a, which are evenly distributed within the groove structure 2111 of the first support member 211. Obviously, this is not a limitation of the present application. In other embodiments, the number of stepped support portions 2112a can also be one, two, four, or more. When there are multiple stepped support portions 2112a, the spaced apart stepped support portions 2112a can further limit the reversal of the fixing screw 110 to prevent it from exiting the target organ tissue. Further, please continue to refer to Figures 7 and 9. In Figure 9, the axis structure 2112 of the first support member 211 also includes a connecting shaft 2112b located at the center of the axis structure 2112. In Figure 7, the connecting member 120 includes an annular base 121 and an L-shaped connecting portion 122 arranged at the proximal end of the annular base 121 (i.e., the right end of the connecting member 120 in Figure 7), wherein the inner diameter of the annular base 121 is adapted to the outer diameter of the connecting shaft 2112b. The top end of the L-shaped connecting portion 122 (the left end of the L-shaped connecting portion 122 in Figure 7) is connected to the annular base 121 and partially protrudes radially outward from the annular base 121. The bending direction of the L-shaped connecting portion 122 is contrary to the spiral direction of the fixing spiral 110. When the connecting member 120 is fixed to the first supporting member 211, the annular base 121 is looped on the connecting shaft 2112b, and the bottom of the L-shaped connecting portion 122 is nested between the second block structure of one of the stepped supporting portions 2112a and the bottom of the groove structure 2111 of the first supporting member 211.Therefore, the bending direction of the L-shaped connecting portion 122 is contrary to the spiral direction of the fixing spiral 110, and the stacked and sleeved connection between the L-shaped connecting portion 122 and the second block-shaped structure not only makes the connection between the connecting member 120 and the first support member 211 in the axial direction more secure, but also can limit the circumferential rotation of the connecting member, thereby further limiting the reversal of the fixing spiral 110 to avoid exiting the target organ tissue.

[0107] Specifically, please refer to Figures 10a to 10f. Figure 10a is a cross-sectional view of the first anti-reversal element 221 in Figure 7 when it is subjected to a fourth external force along the axial direction of the anti-reversal fixing structure 1 from the distal end to the proximal end of the anti-reversal fixing structure 1; Figure 10b is a cross-sectional view of the first anti-reversal element 221 in Figure 7 when it is subjected to a fifth external force along the axial direction of the anti-reversal fixing structure 1 from the distal end to the proximal end of the anti-reversal fixing structure 1; Figure 10c is a cross-sectional view of the first anti-reversal element 221 in Figure 7 when it is subjected to a fifth external force along the axial direction of the anti-reversal fixing structure 1 from the distal end to the proximal end of the anti-reversal fixing structure 1; FIG10d is a cross-sectional view of the anti-reversal fixing structure 1 along the axis of the anti-reversal fixing structure 1, viewed from the distal end to the proximal end. FIG10e is a schematic view corresponding to FIG10b, viewed from the distal end to the proximal end. FIG10f is a schematic view corresponding to FIG10c, viewed from the distal end to the proximal end. FIG10a to FIG10f illustrate the bending state of the first anti-reversal portion 2211 when subjected to different external forces (the fourth external force being less than the fifth external force, and the fifth external force being less than the sixth external force). The outward bending of the first anti-reversal portion 2211 along the radial direction of the anti-reversal fixing structure 1 increases the radial profile of the first anti-reversal element 221 (thereby increasing the radial contact area of ​​the first anti-reversal element 221 with the target organ tissue). Moreover, the positional relationship between the first support member 211, the fixing screw 110 and the first anti-reversal element 221 when connected can be more clearly seen, further confirming that the setting of the first support member 211 can not only ensure the firmness of the connection between the fixing screw 110, the first welding plate 131, the connecting member 120 and the first anti-reversal element 221, but also effectively prevent the fixing screw 110 from undergoing large deformation in the radial direction.

[0108] Example 3

[0109] This embodiment provides an anti-reversal fixing structure 1. As previously mentioned, the anti-reversal fixing structure 1 provided in this embodiment is shown in FIG11 . By comparing FIG11 with FIG1 and FIG2 , it can be seen that, similar to the anti-reversal fixing structure 1 provided in Example 1, the anti-reversal fixing structure 1 provided in this embodiment also includes a fixing substructure 100, an anti-reversal substructure 200, and a mounting substructure 300. The mounting substructure 300 of the anti-reversal fixing structure 1 provided in this embodiment also includes a mounting member 310 and a sealing disk 320. However, unlike Example 1, the fixing substructure 100 of the anti-reversal fixing structure 1 provided in this embodiment only includes a fixing screw 110 and a welding disk (for ease of distinction and description, denoted as the first welding disk 131 in Example 1 and the second welding disk 132 in this embodiment), and does not include a connecting member 120. The anti-reversal substructure 200 of the anti-reversal fixing structure 1 provided in this embodiment only includes an anti-reversal element (for ease of distinction and description, denoted as the first anti-reversal element 221 in Example 1 and the second anti-reversal element 222 in this embodiment), and does not include a support member. Since the anti-reversal substructure 200 provided in this embodiment does not include a support member, in order to adapt to the anti-reversal substructure 200, the second welding plate 132 and the mounting member 310 in this embodiment are different from those in Example 1. To avoid redundant description, the same parts as the anti-reversal fixing structure 1 provided in Example 1 or Example 2, such as the fixing screw 110, the sealing plate 320, and the materials of each component, will not be further described in this embodiment.

[0110] In addition, as previously described, the distal end of the first anti-reversal portion 2221 of the anti-reversal fixing structure 1 provided in this embodiment can bend and at least partially abut the target organ tissue, including: the distal end of the first anti-reversal portion 2221 can bend axially toward the proximal end and at least partially abut the target organ tissue. It should be noted that for portions not described in detail in this embodiment, please refer to the relevant drawings of this embodiment and the relevant descriptions of Example 1 or Example 2 for an adaptive understanding. The following only describes the differences from Example 1.

[0111] In some exemplary embodiments, please refer to Figures 11 and 12, wherein Figure 12 shows a schematic structural diagram of the fixing screw 110 and the second welding plate 132 in Figure 11. As can be seen from Figures 11 and 12, the fixing substructure 100 of the anti-reversal fixing structure 1 provided in this embodiment also includes an annular second welding plate 132; the distal end of the second welding plate 132 (i.e., the upper end of the second welding plate 132 in Figure 12) is provided with a second positioning structure 1322 extending in a direction away from the anti-reversal substructure 200, and the proximal end of the fixing screw 110 abuts against the side of the second positioning structure 1322 and connects the fixing screw 110 to the second welding plate 132 according to a preset spiral direction. Thus, the spiral direction of the fixing screw 110 is positioned by the second positioning structure 1322, which not only makes the assembly of the fixing screw 110 and the second welding plate 132 simpler and faster, but also ensures that the fixing screw 110 is fixedly connected to the second welding plate 132 according to the preset spiral direction, thereby laying the foundation for effectively limiting the reversal of the fixing screw 110.

[0112] In some exemplary embodiments, a third welding surface 1321 is provided on the annular surface of the distal end of the second welding disc 132, and the fixing screw 110 is provided with a first welding surface 112 for welding and matching with the third welding surface 1321. Thus, by providing the third welding surface 1321, it is not only easier to fix the fixing screw 110 to the second welding disc 132, but the annular second welding disc 132 can also provide better support for the fixing screw 110. This improves the firmness of the connection between the fixing screw 110 and the second welding disc 132, thereby giving the fixing screw 110 greater rigidity and bearing capacity. Optionally, the second positioning structure 1322 is a block-shaped protruding structure. Specifically, when welding the fixing spiral 110 and the second welding plate 132, first, the end of the fixing spiral 110 with the first welding surface 112 is placed against the side of the second positioning structure 1322 facing the third welding surface 1321; then, the first welding surface 112 and the third welding surface 1321 are welded along the spiral direction of the fixing spiral 110, thereby realizing the welding connection between the first welding surface 112 and the third welding surface 1321 according to the preset spiral direction.

[0113] In some exemplary embodiments, please continue to refer to Figures 11 and 12. As can be seen from Figures 11 and 12, the projection of the fixing screw 110 along its axial direction onto the third welding surface 1321 is located within the region where the third welding surface 1321 is located. Thus, by limiting the projection of the fixing screw 110 along its axial direction onto the third welding surface 1321 to the region where the third welding surface 1321 is located, not only is the welding assembly of the fixing screw 110 and the second welding plate 132 more facilitated, further enhancing the support provided by the second welding plate 132 to the fixing screw 110, but it also facilitates the integral molding of the second anti-reversal element 222 described below. More specifically, as can be seen from Figures 11 and 12, the distal end of the second welding plate 132 is stepped, with a higher center and lower periphery, and the third welding surface 1321 is disposed on the lower peripheral annular surface. Therefore, the projection surface of the fixing spiral 110 along its axial direction on the third welding surface 1321 is located in the area where the third welding surface 1321 is located (i.e., the outer annular surface). The fixing spiral 110 can be restricted within a preset range through the higher middle part and the first anti-reversal portion 2221 of the second anti-reversal element 222 below, thereby ensuring the radial stability between the fixing spiral 110 and the second welding plate 132, thereby further improving the reliability of the deformation of the fixing spiral 110 along the axial direction of the anti-reversal fixing structure 1.

[0114] Optionally, the second welding pad 132 is made of a biocompatible metal material. Specifically, biocompatible metal materials used to make the second welding pad 132 include, but are not limited to, stainless steel, nickel-titanium alloy, MP35N, and 35NLT. For the advantages of biocompatible metal materials, please refer to the description of the first welding pad 131 above and will not be repeated here.

[0115] In some exemplary embodiments, please refer to FIG. 11 and FIG. 13 , wherein FIG. 13 is a schematic structural diagram of the second anti-reversal element 222 , the second welding plate 132 (not labeled in FIG. 13 ), and the fixing screw 110 in FIG. 11 . The anti-reversal substructure 200 also includes a second anti-reversal element 222, which includes the first anti-reversal part 2221, the first anti-reversal chassis 2222 and at least one third anti-reversal part 2223. The first anti-reversal part 2221 and the third anti-reversal part 2223 are both circumferentially arranged at the distal end of the first anti-reversal chassis 2222 and extend circumferentially in the same direction and contrary to the screw-out direction of the fixing screw 110. The first anti-reversal part 2221 is located on the outside of the third anti-reversal part 2223; the distal end of the first anti-reversal chassis 2222 is located between the first anti-reversal part 2221 and the third anti-reversal part 2223, and the end surface is connected to the distal end of the second welding plate 132 (optionally, fixedly connected), and the proximal end of the first anti-reversal chassis 2222 is connected to the distal end of the mounting substructure 300 (optionally, fixedly connected). Therefore, through the setting of the first anti-reversal chassis 2222, not only can the foundation be laid for the setting of the first anti-reversal part 2221 and the third anti-reversal part 2223, but it can also be more convenient for the fixed connection of the second anti-reversal element 222 with the second welding plate 132 and the mounting substructure 300 (specifically, the mounting part 310 below); compared with Example 1, the anti-reversal fixing structure 1 provided in this embodiment further simplifies the structure of the anti-reversal substructure 200, thereby eliminating the assembly steps of the anti-reversal substructure 200 in Example 1 or Example 2, thereby improving production efficiency. Furthermore, by designing the first anti-reversal portion 2221 and the third anti-reversal portion 2223 to be circumferentially arranged at the distal end of the first anti-reversal chassis 2222 and extending circumferentially in the same direction and contrary to the screwing-out direction of the fixing spiral 110, the first anti-reversal portion 2221 and the third anti-reversal portion 2223 can be bent from the distal end to the proximal end along the axial direction of the anti-reversal fixing structure 1 when the target organ tissue exerts an axial force on the anti-reversal fixing structure 1, thereby increasing the contact area between the first anti-reversal portion 2221 and the third anti-reversal portion 2223 and the target organ tissue, thereby increasing the resistance of the overall implantable medical device to continue to enter the myocardium axially and reducing the risk of perforation. Furthermore, the distal end of the first anti-reversal chassis 2222 has a partial end surface located between the first anti-reversal portion 2221 and the third anti-reversal portion 2223 and is fixedly connected to the distal end of the second welding plate 132, which further enables the first anti-reversal portion 2221 and the third anti-reversal portion 2223 to limit the fixing spiral 110 in the radial direction, thereby improving the stability of the fixing spiral 110.

[0116] Specifically, referring to FIG. 13 , similar to the first anti-reversal portion 2221 of the first embodiment, the first anti-reversal portion 2221 and the third anti-reversal portion 2223 of the second anti-reversal element 222 of the anti-reversal fixing structure 1 provided in this embodiment are also plate-shaped structures. The first anti-reversal portion 2221 also includes a first inclined surface 2221a, a second inclined surface 2221b, and a third inclined surface 2221c. The first angle between the first inclined surface 2221a and the cross-section of the anti-reversal fixing structure 1 can be selected to be between 30° and 60°, and the second angle between the second inclined surface 2221b and the cross-section of the anti-reversal fixing structure 1 can be selected to be between 60° and 90° (greater than the first angle between the first inclined surface 2221a and the cross-section of the anti-reversal fixing structure 1), i.e., the second angle is greater than the first angle. Thus, by adopting a design method in which the inclination direction of the first bevel 2221a is contrary to the rotation direction of the fixing screw 110 and the second angle is greater than the first angle, the difference in resistance between the reverse rotation and the forward rotation of the anti-reversal fixing structure 1 can be increased, so that the resistance of the anti-reversal fixing structure is greater when it rotates in the reverse direction. The third angle between the third bevel 2221c and the cross section of the anti-reversal fixing structure 1 is between 30° and 60°. Thus, when the first anti-reversal portion 2221 is subjected to the force exerted on its axis by the target organ tissue, it can bend from the distal end to the proximal end along the axis direction of the anti-reversal fixing structure 1, thereby increasing the contact area between the first anti-reversal portion 2221 and the target organ tissue, thereby increasing the resistance of the implantable medical device as a whole to continue to enter the myocardium along the axial direction, and reducing the risk of perforation.

[0117] Similar to the first anti-reversal portion 2221, the third anti-reversal portion 2223 includes a first bevel 2223a and a second bevel 2223b, wherein the first angle between the first bevel 2223a and the cross-section of the anti-reversal fixing structure 1 can be selected to be between 30° and 60°, and the second angle between the second bevel 2223b and the cross-section of the anti-reversal fixing structure 1 can generally be selected to be between 60° and 90° (greater than the angle between the first bevel 2223a and the cross-section of the anti-reversal fixing structure 1), that is, the second angle is greater than the first angle. Therefore, the design method in which the inclination direction of the first bevel 2223a is contrary to the rotation direction of the fixing screw 110 and the second angle is greater than the first angle can further increase the difference in resistance between the reverse rotation and the forward rotation of the anti-reversal fixing structure 1, so that the resistance of the anti-reversal fixing structure is greater when it rotates in the reverse direction.

[0118] Optionally, the second anti-reversal element 222 is made of a flexible, biocompatible, non-metallic material. Specifically, biocompatible non-metallic materials used to make the second anti-reversal element 222 include, but are not limited to, silicone, nylon, woven animal hair, woven plant fiber, and other materials that allow for significant deformation. These materials are not described in detail here. The second anti-reversal element 222 is made of a flexible, biocompatible non-metallic material and is susceptible to deformation when subjected to external forces.

[0119] It should be noted that the present application does not limit the number of the first anti-reversal portion 2221 and the third anti-reversal portion 2223, which can be 1, 2 or more. However, as an option, the number of the first anti-reversal portion 2221 and the third anti-reversal portion 2223 are both 2-8.

[0120] Specifically, please refer to Figures 14a to 14d. Figure 14a is a front view of the second anti-reversal element 222 in Figure 11 when subjected to the seventh external force along the axial direction of the anti-reversal fixing structure 1 from the distal end to the proximal end of the anti-reversal fixing structure 1; Figure 14b is a front view of the second anti-reversal element 222 in Figure 11 when subjected to the eighth external force along the axial direction of the anti-reversal fixing structure 1 from the distal end to the proximal end of the anti-reversal fixing structure 1; Figure 14c is a corresponding schematic diagram of the state of Figure 14a observed from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axial direction of the anti-reversal fixing structure 1; and Figure 14d is a corresponding schematic diagram of the state of Figure 14b observed from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axial direction of the anti-reversal fixing structure 1. Figures 14a to 14d not only show the bending state of the first anti-reversal portion 2221 when subjected to different external forces (where the seventh external force is less than the eighth external force), but also show that the first anti-reversal portion 2221 bends proximally along the axial direction of the anti-reversal fixing structure 1, thereby reducing the axial height of the first anti-reversal portion 2221 (thereby increasing the contact area between the first anti-reversal portion 2221 and the target organ tissue). Furthermore, the positional relationship between the fixing screw 110, the second welding plate 132, and the second anti-reversal element 222 when connected can be more clearly seen.

[0121] In some exemplary embodiments, please continue to refer to Figures 11, 12, 13, 15 and 16, wherein Figure 15 is a schematic structural diagram of the mounting member 310 in Figure 11; Figure 16 is a cross-sectional view along the axial direction of the fixing screw 110, the second welding plate 132, the second anti-reversal element 222 and the mounting member 310 in Figure 11 after being integrally formed. As can be seen from Figure 11, the distal end of the first anti-reversal base plate 2222 extends away from the mounting substructure 300 to form a first annular step structure 22221. Along the axial direction of the anti-reversal fixing structure 1, the outer diameter of the distal end of the first annular step structure 22221 is larger than the outer diameter of the proximal end thereof, and the third anti-reversal portion 2223 is provided at the distal end of the first annular step structure 22221; the second welding plate 132 is sleeved on the outer side of the proximal end of the first annular step structure 22221, and the inner shape of the second welding plate 132 is adapted to the outer shape of the proximal end of the first annular step structure 22221. Therefore, the second welding plate 132 and the first anti-reversal chassis 2222 are connected in a manner in which annular steps are nested with each other, thereby ensuring the firmness of the connection between the second welding plate 132 and the second anti-reversal element 222 along the axial direction of the anti-reversal fixing structure 1.

[0122] In some exemplary embodiments, please continue to refer to Figures 11 and 12, which show that at least one first limiting structure 1323 is formed on the inner side of the second welding plate 132, and a second limiting structure 22222 is formed on the outer side of the proximal end of the first annular step structure 22221 to match the first limiting structure 1323. Thus, the first limiting structure 1323 of the second welding plate 132 and the second limiting structure 22222 of the first anti-reversal base plate 2222 cooperate to limit circumferential rotation between the second welding plate 132 and the second anti-reversal element 222.

[0123] Optionally, in some exemplary embodiments, the first limiting structure 1323 and the second limiting structure 22222 are matched in a concave-convex manner. Specifically, the first limiting structure 1323 is a through slot whose extension direction is consistent with the axial direction of the anti-reversal fixing structure 1, and the second limiting structure 22222 is a protruding block that matches the through slot. It should be noted that the above is only a description of an optional embodiment, and not a limitation of the present application. In some other embodiments, the first limiting structure 1323 can also be designed as a protruding block and the second limiting structure 22222 can be designed as a through slot; in other embodiments, the first limiting structure 1323 and the second limiting structure 22222 can also be mutually staggered tooth-shaped connections, which are no longer listed one by one.

[0124] Optionally, the number of the first limiting structures 1323 and the second limiting structures 22222 is 2-8. Thus, the 2-8 first limiting structures 1323 and the second limiting structures 22222 will not make the processing of the second welding disc 132 and the second anti-reversal element 222 too complicated, and can also ensure that there is a reasonable spacing between the first limiting structures 1323 and the second limiting structures 22222 and a good circumferential distribution balance, thereby limiting the circumferential rotation of the second welding disc 132, and further effectively restricting the displacement of the second welding disc 132 and the second anti-reversal element 222 along the radial direction of the anti-reversal fixing structure 1, thereby improving the firmness of the connection between the second welding disc 132 and the second anti-reversal element 222 along the radial direction of the anti-reversal fixing structure 1.

[0125] In some exemplary embodiments, please continue to refer to Figures 11, 15, and 16, in which the proximal end of the first anti-reversal chassis 2222 (i.e., the right end of the first anti-reversal chassis 2222 in Figure 11) extends toward the mounting substructure 300 to form a second annular step structure 22223. Along the axial direction of the anti-reversal fixed structure 1, the outer diameter of the proximal end of the second annular step structure 22223 is larger than the outer diameter of the distal end. The mounting substructure 300 includes a mounting member 310, which is sleeved on the outer side of the distal end of the second annular step structure 22223, and the inner shape of the mounting member 310 is adapted to the outer shape of the distal end of the second annular step structure 22223. Therefore, the second anti-reversal chassis 2232 of the second anti-reversal element 222 and the mounting member 310 adopt a connection method in which the annular steps are nested with each other, ensuring the firmness of the connection between the second anti-reversal element 222 and the mounting member 310 along the axial direction of the anti-reversal fixed structure 1.

[0126] In some exemplary embodiments, referring to FIG. 15 , the mounting member 310 is annular, with at least one third limiting structure 312 formed on the inner side of the mounting member 310. The outer side of the distal end of the second annular step structure 22223 is provided with a fourth limiting structure 22224 that mates with the third limiting structure 312. Thus, the third limiting structure 312 of the mounting member 310 and the fourth limiting structure 22224 of the first anti-reversal chassis 2222 cooperate to limit circumferential rotation between the mounting member 310 and the second anti-reversal element 222.

[0127] Optionally, the third limiting structure 312 and the fourth limiting structure 22224 are matched in a concave-convex manner. Specifically, the third limiting structure 312 is a through slot with an extension direction consistent with the axial direction of the anti-reversal fixing structure 1, and the fourth limiting structure 22224 is a protruding block that matches the through slot. It should be noted that the above is only a description of an optional embodiment, and not a limitation of the present application. In some other embodiments, the third limiting structure 312 can also be designed as a protruding block and the fourth limiting structure 22224 can be designed as a through slot; in other embodiments, the third limiting structure 312 and the fourth limiting structure 22224 can also be mutually staggered tooth-shaped connections, which are no longer listed one by one.

[0128] Optionally, the number of the third limiting structures 312 and the fourth limiting structures 22224 is 2-8. Thus, the 2-8 third limiting structures 312 and the fourth limiting structures 22224 will not make the processing of the second welding plate 132 and the second anti-reversal element 222 too complicated, and can also ensure that there is a reasonable spacing between the third limiting structures 312 and the fourth limiting structures 22224 and a good circumferential distribution balance, thereby limiting the circumferential rotation of the second anti-reversal element 222, and further effectively restricting the displacement between the second anti-reversal element 222 and the mounting member 310 along the radial direction of the anti-reversal fixing structure 1, thereby improving the firmness of the connection between the second anti-reversal element 222 and the mounting member 310 along the radial direction of the anti-reversal fixing structure 1.

[0129] Example 4

[0130] The present embodiment provides an anti-reversal fixing structure 1. As mentioned above, the anti-reversal fixing structure 1 provided in the present embodiment is shown in FIG17 . By comparing FIG17 with FIG1 and FIG2 , it can be seen that: basically similar to the anti-reversal fixing structure 1 provided in the first embodiment, the anti-reversal fixing structure 1 provided in the present embodiment also includes a fixed substructure 100, an anti-reversal substructure 200 and a mounting substructure 300. The mounting substructure 300 of the anti-reversal fixing structure 1 provided in the present embodiment also includes a mounting member 310 and a sealing disk 320. However, what is different from the first embodiment is that, first of all, the fixed substructure 100 of the anti-reversal fixing structure 1 provided in the present embodiment only includes a fixing spiral 110, and does not include a welding disk and a connecting member 120. In other words, there is neither the connecting member 120 and the first welding disk 131 in the first embodiment, nor the second welding disk 132 in the third embodiment. Secondly, unlike the anti-reversal substructure 200 of the anti-reversal fixing structure 1 provided in the third embodiment, which only includes an anti-reversal element (for the convenience of distinction and description, denoted as the second anti-reversal element 222 in the third embodiment), the anti-reversal substructure 200 of the anti-reversal fixing structure 1 provided in this embodiment includes an anti-reversal element (for the convenience of distinction and description, denoted as the first anti-reversal element 221 in the first embodiment and the third anti-reversal element 223 in the present embodiment) and a support member (denoted as the first support member 211 in the first embodiment and the second support member 212 in the present embodiment). However, unlike the first support member 211 being disposed close to the fixing screw 110 and the first anti-reversal element 221 being disposed close to the fixing substructure 100 in the first embodiment, the third anti-reversal element 223 in the present embodiment is disposed close to the fixing screw 110 and the second support member 212 is disposed close to the fixing substructure 100. To avoid redundancy, only the differences from the first embodiment will be described below. For portions not described in detail in this embodiment, please refer to the relevant drawings of this embodiment and the relevant descriptions of the first, second, and / or third embodiments for an adaptive understanding.

[0131] In some exemplary embodiments, specifically, please refer to Figures 17, 18 and 19, wherein Figure 18 is a structural schematic diagram of the fixing screw 110 and the third anti-reversal element 223 in Figure 17; Figure 19 is a structural schematic diagram of the second support member 212 in Figure 17. As can be seen from Figures 17, 18 and 19, the anti-reversal substructure 200 of the anti-reversal fixing structure 1 provided in this embodiment includes a third anti-reversal element 223 and a second support member 212, and the third anti-reversal element 223 includes the first anti-reversal part 2231 and the second anti-reversal chassis 2232, the first anti-reversal part 2231 is circumferentially spaced on the second anti-reversal chassis 2232, the distal end face of the second anti-reversal chassis 2232 is connected to the proximal end of the fixing spiral 110 (optionally, fixedly connected), the proximal end of the second anti-reversal chassis 2232 is connected to the distal end of the second support member 212 (optionally, fixedly connected), the proximal end of the second support member 212 is connected to the distal end of the mounting substructure 300 (optionally, the mounting member 310) (optionally, fixedly connected), and optionally, the second anti-reversal chassis 2232, the third anti-reversal chassis structure 2121 in Figure 17 below, and the mounting member 310 are integrally injection molded. Thus, by fixedly connecting the proximal end of the fixing screw 110 to the distal end face of the second anti-reversal chassis 2232, the second anti-reversal chassis 2232 provides support for the fixing screw 110. Furthermore, the proximal end of the second anti-reversal chassis 2232 is fixedly connected to the distal end of the second support member 212. The provision of the second support member 212 can provide sufficient support force for the second anti-reversal chassis 2232. This provision also lays the foundation for when the distal end of the first anti-reversal portion 2231 is subjected to an external force from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axis of the anti-reversal fixing structure 1, the distal end of the first anti-reversal portion 2231 can bend from the distal end to the proximal end along the axis of the anti-reversal fixing structure 1 and at least partially resist the target organ tissue. In addition, the design of the second anti-reversal chassis 2232 is also more conducive to the integrated molding of the third anti-reversal element 223.

[0132] In some exemplary embodiments, referring to FIG. 17 , the distal end of the second anti-reversal chassis 2232 extends away from the mounting substructure 300 to form a third annular step structure 22321. Along the axial direction of the anti-reversal fixing structure 1, the outer diameter of the third annular step structure 22321 is smaller than the outer diameter of the second anti-reversal chassis 2232. The first anti-reversal portion 2231 is located on the circumferential sidewall of the second anti-reversal chassis 2232. The proximal end of the fixing screw 110 is connected (optionally, fixedly connected) to the distal end surface of the second anti-reversal chassis 2232 and sleeved on the third annular step structure 22321. Thus, by sleeved on the third annular step structure 22321 and disposed on the distal end surface of the second anti-reversal chassis 2232, sufficient support force can be provided for the fixing screw 110. Combined with the first anti-reversal portion 2231 arranged on the circumferential side wall of the second anti-reversal chassis 2232, the fixing spiral 110 can be restricted within a preset range, thereby enabling better radial positioning of the fixing spiral 110, thereby ensuring radial stability between the fixing spiral 110 and the third anti-reversal element 223.

[0133] In some exemplary embodiments, referring to Figures 17, 18, and 19, the inner shape of the third annular step structure 22321 is adapted to the distal shape of the second support member 212. Thus, by configuring the inner shape of the third annular step structure 22321 to be adapted to the distal shape of the second support member 212, the secure connection between the third annular step structure 22321 and the second support member 212 is improved.

[0134] In some exemplary embodiments, as shown in FIG18 , a third positioning structure 22322 is provided on the proximal end surface of the second anti-reversal chassis 2232. The third positioning structure 22322 extends toward the direction of the stator structure 100. The proximal end of the fixing screw 110 abuts against the side of the third positioning structure 22322, thereby connecting the fixing screw 110 to the second anti-reversal chassis 2232 according to a predetermined spiral direction. Optionally, the third positioning structure 22322 is a block-shaped protruding structure, and the thickness of the block-shaped protruding structure along the axial direction is adapted to the thickness of the end of the fixing screw 110 abutting against it. Therefore, the spiral direction of the fixed spiral 110 is positioned by the third positioning structure 22322, which not only makes the assembly of the fixed spiral 110 and the third anti-reversal element 223 (simplified to the assembly between the fixed spiral 110 and the second anti-reversal chassis 2232) simpler and faster, but also ensures that the fixed spiral 110 is fixedly connected to the second welding plate 132 according to the preset spiral direction, thereby laying the foundation for effectively limiting the reversal of the fixed spiral 110.

[0135] In some exemplary embodiments, a fourth welding surface 22323 is provided on the proximal end surface of the second anti-reversal chassis 2232. The fourth welding surface 22323 abuts the third positioning structure 22322. The fixing screw 110 is provided with a first welding surface 112 for welding to the fourth welding surface 22323. The first anti-reversal portion 2231 is located outside the fourth welding surface 22323. Thus, the provision of the fourth welding surface 22323 not only facilitates the secure connection between the fixing screw 110 and the third anti-reversal element 223 (simplified to the assembly between the fixing screw 110 and the second anti-reversal chassis 2232), but also provides better support for the fixing screw 110 through the annular shape (the third annular step structure 22321). This enhances the secure connection between the fixing screw 110 and the third anti-reversal element 223, thereby providing the fixing screw 110 with greater rigidity and bearing capacity. Optionally, the third positioning structure 22322 abuts against one side of the fourth welding surface 22323 along the radial direction. Specifically, when welding the fixing screw 110 and the third anti-reversal element 223, first, the end of the fixing screw 110 provided with the first welding surface 112 is abutted against the side of the third positioning structure 22322 facing the fourth welding surface 22323; then, the first welding surface 112 and the fourth welding surface 22323 are welded along the spiral direction of the fixing screw 110, thereby achieving a welded connection between the first welding surface 112 and the fourth welding surface 22323 according to the preset spiral direction.

[0136] In some exemplary embodiments, referring again to Figures 17 and 18 , the projection of the fixing screw 110 along its axis onto the fourth welding surface 22323 is located within the region where the fourth welding surface 22323 is located. Thus, by limiting the projection of the fixing screw 110 along its axis onto the fourth welding surface 22323 to the region where the fourth welding surface 22323 is located, assembly of the fixing screw 110 and the third anti-reversal element 223 is facilitated.

[0137] Specifically, the third anti-reversal element 223 is made of a flexible biocompatible metal material. Thus, the third anti-reversal element 223 is made of a flexible biocompatible metal material (optionally a biocompatible metal material that allows for greater deformation). On the one hand, the biocompatible material is compatible with the target organ tissue and will not cause immune reactions and rejection reactions, thereby ensuring the safety of the anti-reversal fixing structure 1 after implantation into the target organ tissue. On the other hand, the metal material can also lay the foundation for providing sufficient support for the fixing spiral 110. Specifically, the material of the biocompatible metal material includes but is not limited to stainless steel, nickel titanium alloy, MP35N and 35NLT, etc.

[0138] Specifically, please refer to Figures 20a to 20d, Figure 20a is a main view of the third anti-reversal element 223 in Figure 17 when it is subjected to the ninth external force along the axial direction of the anti-reversal fixing structure 1 from the distal end to the proximal end of the anti-reversal fixing structure 1; Figure 20b is a main view of the third anti-reversal element 223 in Figure 17 when it is subjected to the tenth external force along the axial direction of the anti-reversal fixing structure 1 from the distal end to the proximal end of the anti-reversal fixing structure 1; Figure 20c is a corresponding schematic diagram observed from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axial direction of the anti-reversal fixing structure 1 in the state of Figure 20a; Figure 20d is a corresponding schematic diagram observed from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axial direction of the anti-reversal fixing structure 1 in the state of Figure 20b. From Figures 20a to 20d, it can be seen not only that the first anti-reversal portion 2231 bends proximally along the axial direction of the anti-reversal fixing structure 1 when subjected to different external forces (where the ninth external force is less than the tenth external force), but also that the first anti-reversal portion 2231 bends proximally along the axial direction of the anti-reversal fixing structure 1, thereby reducing the axial height of the first anti-reversal portion 2231 (thereby increasing the contact area between the first anti-reversal portion 2231 and the target organ tissue). Furthermore, the positional relationship of the third anti-reversal element 223 when connected to the fixing screw 110, the second support member 212, and the mounting member 310 can be more clearly seen, further confirming that the provision of the second support member 212 not only ensures the secure connection between the fixing screw 110, the third anti-reversal element 223, and the mounting member 310, but also effectively prevents the fixing screw 110 from undergoing significant radial deformation through the cooperation of the second support member 212, the third anti-reversal element 223, and the mounting member 310.

[0139] Please continue to refer to Figures 17, 19, and 21, wherein Figure 21 is a cross-sectional view along the axial direction of the fixed screw 110, the third anti-reversal element 223, the second support member 212, and the mounting member 310 in Figure 17 after being integrally formed. It can be seen from Figures 17, 19, and 21 that the second support member 212 includes a third anti-reversal chassis structure 2121. In some embodiments, the distal end of the third anti-reversal chassis structure 2121 extends toward the stator structure 100 to form a fourth annular step structure 21211. Along the axial direction of the anti-reversal fixed structure 1, the outer diameter of the distal end of the fourth annular step structure 21211 is greater than the outer diameter of its proximal end, and the second anti-reversal chassis 2232 is sleeved on the outer side of the proximal end of the fourth annular step structure 21211. Therefore, by arranging the second anti-reversal chassis 2232 on the proximal outer side of the fourth annular step structure 21211, not only can sufficient support force be provided for the third anti-reversal element 223, and thus sufficient support force can be provided for the fixing spiral 110; but also the firmness of the connection between the third anti-reversal element 223 and the second support member 212 along the axial direction of the anti-reversal fixing structure 1 can be ensured.

[0140] In some further exemplary embodiments, the proximal end of the third anti-reversal chassis structure 2121 extends toward the mounting substructure 300 to form a fifth annular step structure 21212. Along the axial direction of the anti-reversal fixing structure 1, the outer diameter of the distal end of the fifth annular step structure 21212 is smaller than the outer diameter of the proximal end. The mounting substructure 300 includes a mounting member 310 that is sleeved onto the outer distal end of the fifth annular step structure 21212, and the inner shape of the mounting member 310 matches the outer distal end of the fifth annular step structure 21212. Thus, by sleeved onto the proximal end of the fourth annular step structure 21211, sufficient support is provided for the third anti-reversal element 223 and, in turn, the fixing screw 110. Furthermore, the secure connection between the third anti-reversal element 223 and the second support member 212 along the axial direction of the anti-reversal fixing structure 1 is ensured.

[0141] Specifically, the second support member 212 is made of a biocompatible non-metallic material, such as polypropylene, silicone, polyethylene, polyurethane, nylon, polyurethane, polyimide, polyetheretherketone, and polycarbonate.

[0142] Optionally, in some embodiments, the annular space within the third annular step structure 22321 passes through the second anti-reversal chassis 2232, and at least one fifth limiting structure 22324 is provided on the inner side of the third annular step structure 22321, and a sixth limiting structure 21214 is provided on the outer side of the proximal end of the fourth annular step structure 21211 to match the fifth limiting structure 22324. Thus, the interaction between the fifth limiting structure 22324 and the sixth limiting structure 21214 limits circumferential rotation between the third anti-reversal element 223 and the second support member 212.

[0143] Optionally, the fifth limiting structure 22324 and the sixth limiting structure 21214 are concave-convex. Optionally, the number of the fifth limiting structure 22324 and the number of the sixth limiting structure 21214 are both 2-8. To avoid redundant description of the technical features having the same principles, the advantages of the matching method and number of the fifth limiting structure 22324 and the sixth limiting structure 21214 will not be detailed here. For details, please refer to the above description of the first limiting structure 1323 and the second limiting structure 22222 for adaptive understanding.

[0144] In yet other embodiments, the distal outer side of the fifth annular step structure 21212 is provided with at least one seventh limiting structure 21215. The mounting member 310 (see FIG. 15 of the third embodiment) is annular, and at least one third limiting structure 312 is formed on the inner side of the mounting member 310. The seventh limiting structure 21215 is adapted to mate with the third limiting structure 312. Thus, the interaction between the seventh limiting structure 21215 and the third limiting structure 312 limits circumferential rotation between the second support member 212 and the mounting member 310.

[0145] Optionally, the seventh limiting structure 21215 is mated with the third limiting structure 312 in a concave-convex manner. Optionally, the number of the seventh limiting structure 21215 and the third limiting structure 312 are both 2-8. In order to avoid redundant descriptions of the technical features having the same principles, the advantages of the matching method and number of the seventh limiting structure 21215 and the third limiting structure 312 will not be described in detail here. For details, please refer to the above description of the first limiting structure 1323 and the second limiting structure 22222 for adaptive understanding.

[0146] In one optional embodiment, referring to FIG17 , a support seat 21213 is provided between the fourth annular step structure 21211 and the fifth annular step structure 21212, and the outer diameter of the support seat 21213 matches the outer diameter of the second anti-reversal chassis 2232. Thus, by disposing the support seat 21213 of the second support member 212 between the fourth annular step structure 21211 and the fifth annular step structure 21212, the fixed connection between the second support member 212 and the third anti-reversal element 223, as well as the connection between the second support member 212 and the mounting member 310, is more facilitated. On the other hand, the outer diameter of the support seat 21213 is adapted to the outer diameter of the second anti-reversal chassis 2232, and can provide sufficient supporting force for the third anti-reversal element 223 without increasing the radial dimension, thereby laying the foundation for when the distal end of the first anti-reversal part 2231 is subjected to an external force from the distal end to the proximal end of the anti-reversal fixing structure 1 along the axial direction of the anti-reversal fixing structure 1, the distal end of the first anti-reversal part 2231 can bend from the distal end to the proximal end along the axial direction of the anti-reversal fixing structure 1 and at least partially resist the target organ tissue.

[0147] In some exemplary embodiments, see Figures 17 and 19 . As shown in Figure 19 , the second support member 212 includes at least one fourth anti-reversal portion 2122 circumferentially disposed on the distal end surface of the fourth annular step structure 21211 and extending in a direction opposite to the direction in which the fixing screw 110 is screwed out. The function of the fourth anti-reversal portion 2122 in this embodiment is similar to that of the third anti-reversal portion 2223 in the third embodiment described above. Please refer to the above for further understanding of the adaptability, and no further explanation will be given here.

[0148] Optionally, the fixing screw 110 is located in the gap between the first anti-reversal portion 2231 and the fourth anti-reversal portion 2122, and the axial direction of the fixing screw 110 is parallel to the axial direction of the anti-reversal fixing structure 1. The positional relationship between the first anti-reversal portion 2231, the fixing screw 110, and the fourth anti-reversal portion 2122 in this embodiment is similar to the relationship between the first anti-reversal portion 2221, the fixing screw 110, and the third anti-reversal portion 2223 in the third embodiment above. Please refer to the above for adaptive understanding, and no further explanation will be given here.

[0149] In one exemplary embodiment, the fourth anti-reversal portion 2122 includes a fifth inclined surface 2122a and a sixth inclined surface 2122b adjacent to each other, and the inclination direction of the sixth inclined surface 2122b is opposite to the rotational direction of the fixing screw 110; the fifth inclined surface 2122a forms a fourth angle with the cross section of the anti-reversal fixing structure 1, and the sixth inclined surface 2122b forms a fifth angle with the cross section of the anti-reversal fixing structure 1; the values ​​of the fourth angle and the fifth angle are both non-zero, and the fourth angle is smaller than the fifth angle. The function of the fourth anti-reversal portion 2122 in this embodiment is similar to the structure of the third anti-reversal portion 2223 in the third embodiment above. Please refer to the above for adaptive understanding, and no further explanation will be given here.

[0150] Example 5

[0151] This embodiment provides an implantable medical device, specifically, please refer to Figure 1 in conjunction with Figures 2, 7, 11 and 17. The implantable medical device includes an implantable medical device body (not shown in the figure, including the electrical component 2, power supply component 3, shell 4, distal docking component 5 in Figure 1), an electrode 400, a feedthrough 500 and the anti-reversal fixing structure 1 described in any of the above embodiments. The electrode 400 is connected to the distal end of the anti-reversal fixing structure 1 (optionally, fixedly connected), the proximal end of the anti-reversal fixing structure 1 is connected to the distal end of the implantable medical device body (optionally, fixedly connected), and at least one feedthrough wire 600 of the feedthrough 500 passes through the anti-reversal fixing structure 1 and is electrically connected to the electrode 400.

[0152] Since the implantable medical device provided in this embodiment and the anti-reversal fixing structure 1 provided in the above embodiments belong to the same inventive concept, the implantable medical device provided in this embodiment has at least all the advantages of the anti-reversal fixing structure 1 provided in the above embodiments. They will not be elaborated here. For more details, please refer to the relevant description of the anti-reversal fixing structure 1 above.

[0153] In one exemplary embodiment, the implantable medical device further includes a drug plug 700, which is disposed between the electrode 400 and the anti-reversal fixing structure 1. This makes it easier to administer the drug to the target tissue.

[0154] It should be noted that this application does not limit the specific shapes of the electrode 400 and the drug suppository 700. For example, the electrode 400 can have different head shapes, such as a flat surface, an elliptical surface, a spherical end surface, a pointed surface, a parabolic surface, etc. In addition, the distance between the proximal end of the electrode 400 and the distal end of the fixing spiral 110 can be adjusted based on test results and can generally be set to 0 mm to 1.8 mm. In addition, the distal end of the electrode 400 can be provided with a groove structure (not shown in the figure) for accommodating the drug suppository 700.

[0155] The suppository 700 can be made by mixing silicone resin (such as Loctite silicone adhesive) and steroid drugs (such as dexamethasone acetate), and there is no limitation on this.

[0156] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art can combine and combine different embodiments or examples described in this specification and features of different embodiments or examples without contradiction.

[0157] Compared with the prior art, the anti-reversal fixing structure and implantable medical device provided by this application have the following beneficial effects:

[0158] The anti-reversal fixing structure provided by the present application includes a fixing substructure for fixing the implantable medical device to the target organ tissue, an anti-reversal substructure, and a mounting substructure connected to the distal end of the implantable medical device. In this manner, the anti-reversal fixing structure provided by the present application is not only convenient for fixing the implantable medical device to the target organ tissue; but also this modular design makes the anti-reversal fixing structure simple in structure, easy to process, assemble and maintain, thereby saving manpower, material resources and time costs. Furthermore, the anti-reversal substructure of the anti-reversal fixing structure provided by the present application includes at least one first anti-reversal portion. When the distal end of the first anti-reversal portion is subjected to an external force from the distal end to the proximal end of the anti-reversal fixing structure along the axial direction of the anti-reversal fixing structure, the distal end of the first anti-reversal portion can deviate from the axial direction of the anti-reversal fixing structure and bend outward and at least partially against the target organ tissue. Therefore, the anti-reversal fixing structure provided by the present application can not only effectively prevent the implantable medical device from reversing and exiting the target organ tissue (such as preventing the leadless pacemaker from exiting the myocardial tissue), but also prevent the implantable medical device from continuously moving into the target organ tissue and causing perforation (such as the leadless pacemaker continuously moving into the myocardial tissue and causing perforation of the myocardial tissue), thereby improving the reliability and safety of the implantable medical device after implantation into the target organ tissue.

[0159] Since the implantable medical device provided by the invention belongs to the same inventive concept as the anti-reversal fixing structure provided by this application, the implantable medical device provided by this application has at least all the advantages of the anti-reversal fixing structure provided by this application. They will not be elaborated here. For more details, please refer to the relevant description of the above-mentioned anti-reversal fixing structure.

[0160] In summary, the above embodiments provide a detailed description of the different configurations of the anti-reversal fixing structure and implantable medical device proposed in this application. Of course, the above description is only a description of the optional embodiments of the present application, and is not any limitation to the scope of the present application. The present application includes but is not limited to the configurations listed in the above implementations. Those skilled in the art can draw inferences based on the contents of the above embodiments. Any changes and modifications made by ordinary technicians in the field of this application based on the above disclosures shall fall within the scope of protection of the claims.

Claims

1. An anti-reversal fixing structure, characterized in that: For an implantable medical device; the anti-reversal fixing structure comprises a fixing substructure for fixing the implantable medical device to a target tissue, an anti-reversal substructure and a mounting substructure for connecting to a distal end of the implantable medical device; The fixed substructure is connected to the mounting substructure via the anti-reversal substructure; The anti-reversal substructure includes at least one first anti-reversal portion, and when the distal end of the first anti-reversal portion is subjected to an external force from the distal end to the proximal end of the anti-reversal fixing structure along the axial direction of the anti-reversal fixing structure, the first anti-reversal portion can be deformed.

2. The anti-reversal fixing structure according to claim 1, characterized in that: The anti-reversal substructure includes a plurality of the first anti-reversal portions, and the plurality of the first anti-reversal portions are arranged around the axis of the anti-reversal fixing structure.

3. The anti-reversal fixing structure according to claim 1, characterized in that: The first anti-reversal part is made of a flexible biocompatible material, and the deformation that can occur in the first anti-reversal part reduces the height of the first anti-reversal part along the axial direction and / or increases the projection area of ​​the first anti-reversal part along the axial direction.

4. The anti-reversal fixing structure according to claim 2, characterized in that: The fixing substructure includes a fixing spiral for connecting to the target organ tissue, the axial direction of the fixing spiral is consistent with the axial direction of the anti-reversal fixing structure; the proximal end of the fixing spiral is connected to the distal end of the anti-reversal substructure; the axial direction of the anti-reversal fixing structure is the direction of the line connecting the proximal end and the distal end of the anti-reversal fixing structure.

5. The anti-reversal fixing structure according to claim 4, characterized in that: The stator structure further includes a first welding plate; the distal end of the first welding plate is connected to the proximal end of the fixing spiral, and the proximal end of the first welding plate is connected to the distal end of the anti-reversal substructure.

6. The anti-reversal fixing structure according to claim 5, characterized in that: The first welding pad is made of a biocompatible metal material.

7. The anti-reversal fixing structure according to claim 5, characterized in that: A first welding surface is arranged at the proximal end of the fixing spiral, and a second welding surface is arranged at the distal end of the first welding plate, and the first welding surface and the second welding surface are connected.

8. The anti-reversal fixing structure according to claim 7, characterized in that: The first welding plate further comprises a first positioning structure for positioning the spiral direction of the fixing spiral, wherein the first positioning structure enables the first welding surface of the fixing spiral to be welded to the second welding surface according to a preset spiral direction.

9. The anti-reversal fixing structure according to claim 5, characterized in that: The first welding pad further includes a welding pad mounting portion located at a proximal end of the first welding pad, wherein the welding pad mounting portion is adapted to and connected to a distal end of the anti-reversal substructure.

10. The anti-reversal fixing structure according to claim 4, characterized in that: The fixing substructure also includes a connector, which is at least partially located in the fixing spiral along the axial direction of the anti-reversal fixing structure, and the distal end of the connector is configured to fix the electrode of the implantable medical device; the proximal end of the connector is connected to the distal end of the anti-reversal substructure.

11. The anti-reversal fixing structure according to claim 10, characterized in that: The anti-reversal substructure comprises a first support member and a first anti-reversal element which are circumferentially clamped, wherein the distal end of the first support member is connected to a part of the fixing spiral and the proximal end of the connecting member, and the proximal end of the first support member is connected to the distal end of the mounting substructure; The first anti-reversal element includes the first anti-reversal portion and an anti-reversal element mounting portion, and the first anti-reversal portion is disposed on the anti-reversal element mounting portion.

12. The anti-reversal fixing structure according to claim 11, characterized in that: The distal end of the first anti-reversal portion can be bent and at least partially abut against the target organ tissue, comprising: the distal end of the first anti-reversal portion can be bent radially outward and at least partially abut against the target organ tissue.

13. The anti-reversal fixing structure according to claim 12, characterized in that: The first support member is provided with a side groove and a bottom groove; the first anti-reversal portion is clamped in the side groove at a corresponding position, and the anti-reversal element mounting portion is located in the bottom groove and clamped between the first support member and the mounting substructure.

14. The anti-reversal fixing structure according to claim 13, characterized in that: The extension direction of the first anti-reversal portion is the direction from the proximal end of the first anti-reversal element to the distal end of the first anti-reversal element. The anti-reversal element mounting portion is annular and is sleeved in the bottom groove of the first support member.

15. The anti-reversal fixing structure according to claim 14, characterized in that: The inner surface of the anti-reversal element mounting portion is provided with clamping blocks at intervals, and the clamping blocks extend inwardly along an axial direction perpendicular to the anti-reversal fixing structure; A matching clamping groove is formed at a position of the bottom groove corresponding to the clamping block, and the clamping blocks extend into the clamping grooves one by one.

16. The anti-reversal fixing structure according to claim 12, characterized in that: A groove structure is formed at the distal end of the first support member, a spiral mounting portion is formed on the inner side wall of the groove structure, and the fixing spiral is partially embedded in the spiral mounting portion.

17. The anti-reversal fixing structure according to claim 16, characterized in that: The spiral mounting portion is a spiral groove, and the portion of the fixing spiral embedded in the spiral groove is adapted to the spiral groove.

18. The anti-reversal fixing structure according to claim 17, characterized in that: The first support member also includes at least one second anti-reversal portion arranged on the inner side wall of the groove structure and connected to the spiral mounting portion, the second anti-reversal portion is a recessed structure, the opening direction of the recessed structure is the same as the opening direction of the spiral groove, and the distal end of the recessed structure is also in an open state.

19. The anti-reversal fixing structure according to claim 16, characterized in that: The fixed spiral is a variable pitch structure.

20. The anti-reversal fixing structure according to claim 16, characterized in that: The first support member also includes an axial structure arranged at the bottom of the groove structure, and the shape of the axial structure is adapted to the welding plate mounting portion of the proximal end of the connecting member and the proximal end of the first welding plate of the stator structure; the connecting member and the first welding plate are connected to the first support member via the axial structure.

21. The anti-reversal fixing structure according to claim 12, characterized in that: The first anti-reversal portion is a plate-shaped structure, and the plate-shaped structure is provided with a first inclined surface having a first angle with the cross section of the anti-reversal fixing structure, a second inclined surface having a second angle with the cross section of the anti-reversal fixing structure, and a third inclined surface having a third angle with the cross section of the anti-reversal fixing structure; Among them, the first inclined plane is located at the end of the plate-like structure away from the anti-reversal element mounting portion, and the inclination direction of the first inclined plane is contrary to the screwing-out direction of the fixing screw; the second inclined plane and the third inclined plane both extend from the proximal end of the plate-like structure to the distal end of the plate-like structure, and the third inclined plane is adjacent to the first inclined plane and the second inclined plane, the values ​​of the first angle, the second angle and the third angle are not 0, the value of the first angle is smaller than the value of the second angle, and the value of the third angle is smaller than 90°.

22. The anti-reversal fixing structure according to claim 21, characterized in that: The first anti-reversal portion also includes a fourth slope, which is adjacent to the first slope, the second slope and the third slope, and the fourth slope and the first slope together form the distal end of the plate-like structure; along the circumference of the anti-reversal element mounting portion, the length of the first slope is greater than the length of the fourth slope.

23. The anti-reversal fixing structure according to claim 11, characterized in that: The mounting substructure includes a mounting member having a through hole, and the proximal end of the first supporting member extends into the through hole and is connected to the mounting member.

24. The anti-reversal fixing structure according to claim 4, characterized in that: The distal end of the first anti-reversal portion can be bent and at least partially abut against the target organ tissue, comprising: the distal end of the first anti-reversal portion can be bent axially toward the proximal end and at least partially abut against the target organ tissue.

25. The anti-reversal fixing structure according to claim 24, characterized in that: The stator structure also includes a second annular welding plate; the distal end of the second welding plate is provided with a second positioning structure extending in a direction away from the anti-reversal substructure, and the proximal end of the fixing spiral abuts against the side of the second positioning structure and connects the fixing spiral to the second welding plate according to a preset spiral direction.

26. The anti-reversal fixing structure according to claim 25, characterized in that: A third welding surface is arranged on the annular surface at the distal end of the second welding plate, and a first welding surface for welding with the third welding surface is arranged on the fixing spiral.

27. The anti-reversal fixing structure according to claim 26, characterized in that: The projection surface of the fixing screw along the axial direction of the fixing screw on the third welding surface is located in the area where the third welding surface is located.

28. The anti-reversal fixing structure according to claim 25, characterized in that: The anti-reversal substructure also includes a second anti-reversal element, which includes the first anti-reversal part, a first anti-reversal chassis and at least one third anti-reversal part. The first anti-reversal part and the third anti-reversal part are both circumferentially arranged at the distal end of the first anti-reversal chassis and extend circumferentially in the same direction and contrary to the screw-out direction of the fixed spiral, and the first anti-reversal part is located on the outside of the third anti-reversal part; the distal end of the first anti-reversal chassis is located between the first anti-reversal part and the third anti-reversal part, and the end surface is connected to the distal end of the second welding disk, and the proximal end of the first anti-reversal chassis is connected to the distal end of the mounting substructure.

29. The anti-reversal fixing structure according to claim 28, characterized in that: The distal end of the first anti-reversal chassis extends away from the mounting substructure to form a first annular step structure, along the axial direction of the anti-reversal fixing structure, the outer diameter of the distal end of the first annular step structure is greater than the outer diameter of the proximal end thereof, and the third anti-reversal portion is arranged at the distal end of the first annular step structure; The second welding plate is sleeved on the outer side of the proximal end of the first annular step structure, and the inner side shape of the second welding plate is matched with the outer side shape of the proximal end of the first annular step structure.

30. The anti-reversal fixing structure according to claim 29, characterized in that: At least one first limiting structure is formed on the inner side of the second welding plate, and a second limiting structure matched with the first limiting structure is formed on the outer side of the proximal end of the first annular step structure.

31. The anti-reversal fixing structure according to claim 28, characterized in that: The proximal end of the first anti-reversal chassis extends toward the mounting substructure to form a second annular step structure. Along the axial direction of the anti-reversal fixing structure, the outer diameter of the proximal end of the second annular step structure is larger than the outer diameter of its distal end. The mounting substructure includes a mounting piece, which is sleeved on the outer side of the distal end of the second annular step structure, and the inner side shape of the mounting piece is adapted to the outer side shape of the distal end of the second annular step structure.

32. The anti-reversal fixing structure according to claim 31, characterized in that: The mounting member is annular, and at least one third limiting structure is formed on the inner side of the mounting member. The outer side of the distal end of the second annular step structure has a fourth limiting structure adapted to the third limiting structure.

33. The anti-reversal fixing structure according to claim 24, characterized in that: The anti-reversal substructure includes a third anti-reversal element and a second support member, the third anti-reversal element includes the first anti-reversal part and the second anti-reversal chassis, the first anti-reversal part is circumferentially spaced apart on the second anti-reversal chassis, the distal end surface of the second anti-reversal chassis is connected to the proximal end of the fixing spiral, the proximal end of the second anti-reversal chassis is connected to the distal end of the second support member, and the proximal end of the second support member is connected to the distal end of the mounting substructure.

34. The anti-reversal fixing structure according to claim 33, characterized in that: The distal end of the second anti-reversal chassis extends away from the mounting substructure to form a third annular step structure. Along the axial direction of the anti-reversal fixing structure, the outer diameter of the third annular step structure is smaller than the outer diameter of the second anti-reversal chassis. The first anti-reversal portion is located on the circumferential side wall of the second anti-reversal chassis. The proximal end of the fixing spiral is connected to the distal end face of the second anti-reversal chassis and is sleeved on the third annular step structure.

35. The anti-reversal fixing structure according to claim 34, characterized in that: A third positioning structure is arranged on the proximal end face of the second anti-reversal chassis, and the third positioning structure extends in the direction of the fixed substructure. The proximal end of the fixing spiral abuts against the side of the third positioning structure and connects the fixing spiral to the second anti-reversal chassis according to a preset spiral direction.

36. The anti-reversal fixing structure according to claim 35, characterized in that: A fourth welding surface is provided on the proximal end surface of the second anti-reversal chassis, the fourth welding surface is adjacent to the third positioning structure, and a first welding surface for welding with the fourth welding surface is provided on the fixing spiral; The first anti-reversal portion is located outside the fourth welding surface.

37. The anti-reversal fixing structure according to claim 36, characterized in that: The projection surface of the fixing screw along the axial direction of the fixing screw on the fourth welding surface is located in the area where the fourth welding surface is located.

38. The anti-reversal fixing structure according to claim 34, characterized in that: The second support member includes a third anti-reversal chassis structure, and the third anti-reversal chassis structure has at least one of the following technical features: The distal end of the third anti-reversal chassis structure extends toward the fixed substructure to form a fourth annular step structure, along the axial direction of the anti-reversal fixed structure, the outer diameter of the distal end of the fourth annular step structure is greater than the outer diameter of the proximal end thereof, and the second anti-reversal chassis is sleeved on the outer side of the proximal end of the fourth annular step structure; The proximal end of the third anti-reversal chassis structure extends toward the mounting substructure to form a fifth annular step structure. Along the axial direction of the anti-reversal fixing structure, the outer diameter of the distal end of the fifth annular step structure is smaller than the outer diameter of its proximal end. The mounting substructure includes a mounting piece, which is sleeved on the outer side of the distal end of the fifth annular step structure, and the inner side shape of the mounting piece is adapted to the outer side shape of the distal end of the fifth annular step structure.

39. The anti-reversal fixing structure according to claim 38, characterized in that: The annular space in the third annular step structure passes through the second anti-reversal chassis, and the inner side of the third annular step structure has at least one fifth limiting structure, and the outer side of the proximal end of the fourth annular step structure has a sixth limiting structure adapted to the fifth limiting structure; And / or the outer side of the distal end of the fifth annular step structure has at least one seventh limiting structure, the mounting member is annular, and at least one third limiting structure is formed on the inner side of the mounting member, and the seventh limiting structure is adapted to the third limiting structure.

40. The anti-reversal fixing structure according to claim 38, characterized in that: A support seat is provided between the fourth annular step structure and the fifth annular step structure, and the outer diameter of the support seat is adapted to the outer diameter of the second anti-reversal chassis.

41. The anti-reversal fixing structure according to claim 38, characterized in that: The second support member includes at least one fourth anti-reversal portion, which is circumferentially arranged on the distal end surface of the fourth annular step structure and whose extending direction is contrary to the screwing-out direction of the fixing screw.

42. The anti-reversal fixing structure according to claim 41, characterized in that: The fixing spiral is located in a gap between the first anti-reversal portion and the fourth anti-reversal portion, and an axial direction of the fixing spiral is parallel to an axial direction of the anti-reversal fixing structure.

43. The anti-reversal fixing structure according to claim 41, characterized in that: The fourth anti-reversal portion includes an adjacent fifth inclined plane and a sixth inclined plane, and the inclination direction of the sixth inclined plane is contrary to the screwing-out direction of the fixing spiral; the fifth inclined plane has a fourth angle with the cross-section of the anti-reversal fixing structure, and the sixth inclined plane has a fifth angle with the cross-section of the anti-reversal fixing structure; the values ​​of the fourth angle and the fifth angle are both not 0, and the fourth angle is smaller than the fifth angle.

44. The anti-reversal fixing structure according to any one of claims 1 to 43, characterized in that: The mounting substructure further comprises a sealing disk having a through hole, wherein the sealing disk is connected to the proximal end of the mounting substructure, and the through hole is configured to pass a feedthrough wire of the implantable medical device.

45. An implantable medical device, characterized in that: An implantable medical device comprising an implantable medical device body, an electrode, a feedthrough, and an anti-reversal fixing structure as claimed in any one of claims 1 to 44; The electrode is connected to the distal end of the anti-reversal fixing structure, the proximal end of the anti-reversal fixing structure is connected to the distal end of the implantable medical device body, and at least one feedthrough wire of the feedthrough passes through the anti-reversal fixing structure and is electrically connected to the electrode.

46. ​​The implantable medical device according to claim 45, characterized in that It also includes a medicine plug, which is arranged between the electrode and the anti-reversal fixing structure.

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